ZENBEXUS

WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment [ Contraindications (4) , see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ] . Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS [see Warnings and Precautions (5.2) ] . Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436. SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended [see Warnings and Precautions (5.3) ] . WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO-FETAL TOXICITY • ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment. (4 , 5.1 , 8.1 , 8.3) • Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS. (4 , 5.1 , 8.1 , 8.3) • Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS). (5.2) Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436. SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM • Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS. Anti-thrombotic prophylaxis is recommended. Monitor patients for signs and symptoms of thromboembolic event during treatment with ZENBEXUS. Interrupt ZENBEXUS and initiate anticoagulant therapy as appropriate. (2.3 , 5.3)

5 WARNINGS AND PRECAUTIONS • Neutropenia : Monitor complete blood counts at baseline and throughout treatment. Interrupt, reduce, or discontinue ZENBEXUS and initiate growth factor support as appropriate. (2.3 , 5.4) • Infections : Can cause severe, life-threatening, or fatal infections. Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat appropriately. (5.5) • Second Primary Malignancies : Monitor patients for the development of second primary malignancies. (5.6) 5.1 Embryo-Fetal Toxicity Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animal studies, ZENBEXUS can cause birth defects or embryo-fetal death in humans and is contraindicated for use during pregnancy. Oral administration of iberdomide in pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes including embryo-fetal mortality, alterations to growth, and structural abnormalities [see Use in Specific Populations (8.1) ] . ZENBEXUS is only available through ZENBEXUS REMS [see Warnings and Precautions (5.2) ] . Females of Reproductive Potential Females of reproductive potential must avoid pregnancy while taking ZENBEXUS and for at least 4 weeks after completing therapy. Advise females of reproductive potential of the potential risk to a fetus and to use 2 methods of effective contraception for at least 4 weeks before beginning ZENBEXUS therapy, during therapy, during dose interruptions and for at least 4 weeks after last dose of ZENBEXUS therapy [see Contraindications (4) and Use in Specific Populations (8.1) ] . Two negative pregnancy tests with a sensitivity of at least 25 mIU/mL must be obtained prior to initiating therapy. Pregnancy testing should be performed weekly during the first 4 weeks of treatment. Thereafter, testing should occur every 4 weeks in patients with regular menstrual cycles, or every 2 weeks in patients with irregular menstrual cycles [see Use in Specific Populations (8.3) ] . Females of reproductive potential taking ZENBEXUS must not donate eggs during treatment and for 4 weeks after completion [see Use in Specific Populations (8.3) ] . Males ZENBEXUS may pass into human semen. Advise patients who can impregnate partners to use effective contraception during treatment and for 4 weeks following the discontinuation of ZENBEXUS therapy [see Use in Specific Populations (8.1 , 8.3) ] . Male patients taking ZENBEXUS must not donate sperm during treatment and for 4 weeks after completion [see Use in Specific Populations (8.3) ] . Blood Donation Patients must not donate blood during treatment with ZENBEXUS and for 4 weeks following discontinuation of ZENBEXUS therapy. 5.2 ZENBEXUS REMS ZENBEXUS is available only through a restricted program called ZENBEXUS REMS, because of the risk of embryo-fetal toxicity [see Warnings and Precautions (5.1) ] . Notable requirements of the ZENBEXUS REMS Program include the following: • Prescribers must be certified by enrolling in the ZENBEXUS REMS Program. • Patients must enroll in the ZENBEXUS REMS Program and comply with ongoing monitoring and contraception requirements [see Boxed Warning , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] . • Pharmacies must be certified by enrolling in the ZENBEXUS REMS Program and must only dispense to patients who are authorized to receive ZENBEXUS. • Wholesalers and distributors must only distribute to certified pharmacies. Further information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by telephone at 1-888-423-5436. 5.3 Serious Venous and Arterial Thromboembolism ZENBEXUS can cause serious and life-threatening venous thromboembolic events (deep venous thrombosis and pulmonary embolism) and arterial thromboembolic events (myocardial infarction and stroke). In the EXCALIBER-RRMM study evaluating ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone (IberDd), venous thromboembolic events occurred in 6.4% of patients despite mandatory thromboembolism prophylaxis in the IberDd arm (N=204). The incidence of deep venous thrombosis was 3.4% and the incidence of pulmonary embolism was 1.5%. Arterial thromboembolic events occurred in 3.4% of patients. The incidence of myocardial infarction was 2.0%, and the incidence of stroke (CVA) was 1.5%. Monitor patients for signs and symptoms of thromboembolic events during treatment with ZENBEXUS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors. In patients who develop a thromboembolism, interrupt ZENBEXUS and initiate anticoagulant therapy according to guidelines [see Dosage and Administration (2.3) ] . 5.4 Neutropenia ZENBEXUS can cause severe neutropenia [see Adverse Reactions (6.1) ] . In the EXCALIBER-RRMM study, neutropenia All Grades was reported in 90.2% and Grade 3 in 30.9% and Grade 4 in 53.4% of patients in the IberDd arm (N=204). Febrile neutropenia occurred in 5.4% of patients. The median time to Grade 3 or 4 neutropenia was 21 days. The median duration of Grade 3 or 4 neutropenia was 8 days. Treatment interruption due to neutropenia occurred in 51.5% of patients in the IberDd arm, and discontinuation due to neutropenia was required in 1% of patients in the IberDd arm. Monitor complete blood count throughout treatment with ZENBEXUS. Interrupt, reduce dosage, or discontinue ZENBEXUS, as necessary [see Dosage and Administration (2.3) ] . Initiate GCSF as appropriate per guidelines. 5.5 Infections ZENBEXUS can cause serious infections, including life-threatening or fatal infections [see Adverse Reactions (6.1) ] . Patients with active or uncontrolled infection should not start ZENBEXUS treatment until the infection is controlled. In the EXCALIBER-RRMM study, infections, including opportunistic infections, were reported in 78.9%, Grade 3 in 35.8%, Grade 4 in 3.4%, and fatal infections occurred in 2% of patients in the IberDd arm (N=204). Serious infections occurred in 40% of patients. Discontinuations due to infections occurred in 1.5% of patients. Monitor patients for signs and symptoms of infection prior to and during treatment with ZENBEXUS and treat appropriately. Withhold or reduce the dose based on severity [see Dosage and Administration (2.3) ] . Consider prophylactic anti-infective medications according to current practice guidelines. 5.6 Second Primary Malignancies In the EXCALIBER-RRMM study, at a median follow-up time of 16 months, second primary malignancies (SPM) occurred in 6.9% of patients in the IberDd arm and in 4.9% of patients in the daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) arm [see Adverse Reactions (6.1) ] . Monitor patients for the development of second primary malignancies.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling. • Serious Venous and Arterial Thromboembolism [see Warnings and Precautions (5.3) ] • Neutropenia [see Warnings and Precautions (5.4) ] • Infections [see Warnings and Precautions (5.5) ] • Second Primary Malignancies [see Warnings and Precautions (5.6) ] Most common (≥20%) adverse reactions with ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone are upper respiratory tract infection, fatigue, musculoskeletal pain, pneumonia, diarrhea, motor dysfunction, rash, sleep disorder, hypogammaglobulinemia, COVID-19, and constipation. The most common Grade 3 or 4 (≥30%) laboratory abnormalities are neutrophil count decreased, white blood cell count decreased, and lymphocyte count decreased. (6) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone was evaluated in EXCALIBER-RRMM, a two-stage, phase 3, randomized, multicenter open-label study in patients with relapsed or refractory multiple myeloma (RRMM) after 1 or 2 prior lines of therapy [see Clinical Studies (14) ] . Patients were randomized to receive ZENBEXUS (at 1 of 3 dose levels) in combination with daratumumab and hyaluronidase-fihj and dexamethasone or daratumumab and hyaluronidase-fihj, bortezomib and dexamethasone (DVd) in stage 1, and ZENBEXUS 1 mg in combination with daratumumab and hyaluronidase-fihj and dexamethasone (IberDd) or DVd in stage 2. The MRD Primary Analysis Group included the first 420 patients randomized to ZENBEXUS 1 mg in combination with Dd (N=207) or DVd (N=213) in stage 1 and stage 2. Safety was assessed in patients in the MRD Primary Analysis Group who received at least one dose of the study drug (IberDd: N=204; DVd: N=204). Among patients who received ZENBEXUS, 86% were exposed for 6 months or longer and 73% were exposed for greater than one year. Serious adverse reactions occurred in 58.3% of patients who received ZENBEXUS. Serious adverse reactions in ≥2% of patients included pneumonia (26%), upper respiratory tract infection (6.4%), second primary malignancy (5.9%), neutropenia (4.9%), febrile neutropenia (3.9%), COVID-19 (4.4%), and sepsis (2.9%). Fatal adverse reactions occurred in 10 patients (4.9%) who received ZENBEXUS. Sepsis (1.5%) was the only fatal drug reaction that occurred in more than 1 patient. The following fatal adverse reactions occurred in one patient each: listeria encephalitis, influenza, lung adenocarcinoma, cardiac arrest, large intestine perforation, metabolic acidosis, and respiratory failure. Permanent discontinuation of ZENBEXUS due to an adverse reaction occurred in 7.8% of patients. The most frequent adverse reaction which resulted in permanent ZENBEXUS discontinuation was neutropenia (1%). Dosage interruption of ZENBEXUS due to an adverse reaction occurred in 84% of patients. Adverse reactions which required dosage interruption in >10% of patients included neutropenia, upper respiratory tract infection, pneumonia and COVID-19. Dosage reductions of ZENBEXUS due to an adverse reaction occurred in 29% of patients. Adverse reactions which required dose reductions in >2% of patients included neutropenia, fatigue, pneumonia, and sensory neuropathy. The most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue, musculoskeletal pain, pneumonia, diarrhea, motor dysfunction, rash, sleep disorder, hypogammaglobulinemia, COVID-19, and constipation. The most common Grade 3 to 4 laboratory abnormalities (≥30%) were decreased neutrophils, decreased white blood cells, and decreased lymphocytes. Tables 2 and 3 summarize adverse reactions and laboratory abnormalities, respectively, in the EXCALIBER-RRMM study. Table 2: Adverse Reactions (≥10%) in Patients Who Received ZENBEXUS in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone in EXCALIBER-RRMM Adverse reactions were graded according to NCI CTCAE Version 5.0. Adverse Reaction ZENBEXUS + Daratumumab and Hyaluronidase-fihj + Dexamethasone (IberDd) (n=204) Daratumumab and Hyaluronidase-fihj + Bortezomib + Dexamethasone (DVd) (n=204) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Infections and infestations Upper respiratory tract infection Upper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection, sinusitis, and other related terms. 54 Includes fatal adverse reaction: IberDd (n=1). 6 52 6 Pneumonia Pneumonia includes atypical pneumonia, bacterial pneumonia, lower respiratory tract infection, lung consolidation, viral pneumonia and other related terms. 34 25 17 10 COVID-19 Includes other related terms. 23 3.9 16 2.9 General disorders and administration site conditions Fatigue 36 3.4 33 2.5 Edema 17 0.5 24 1 Pyrexia 14 1 15 1 Musculoskeletal and connective tissue disorders Musculoskeletal pain 35 1.5 33 2.9 Bone pain 11 1 13 0.5 Gastrointestinal disorders Diarrhea 33 4.9 36 6 Constipation 20 0 22 1 Nausea 14 0.5 6 0 Nervous system disorders Motor dysfunction Motor dysfunction includes ataxia, balance disorder, gait disturbance, muscle contracture, muscle spasms, muscular weakness, myopathy, paralysis, peripheral motor neuropathy and other related terms. 26 1.5 17 2.5 Sensory neuropathy Sensory neuropathy includes anosmia, hypoesthesia, mononeuropathy, neuralgia, paresthesia, peripheral neuropathy, peripheral sensory neuropathy, polyneuropathy, radiculopathy and other related terms. 19 4.4 53 6 Dizziness 11 0 9 0.5 Skin and subcutaneous tissue disorders Rash 26 1 15 0.5 Psychiatric disorders Sleep disorder Sleep disorder includes insomnia, restless legs syndrome, sleep disorder and other related terms. 25 2.9 28 1.5 Immune system disorders Hypogammaglobulinemia Hypogammaglobulinemia includes hypogammaglobulinemia, hypoglobulinemia, and other related terms. 24 1 12 0.5 Respiratory, thoracic and mediastinal disorders Cough 18 0.5 14 0.5 Dyspnea 10 0 9 1 Renal and urinary disorders Renal impairment 11 3.4 8 3.9 Vascular disorders Hemorrhage Hemorrhage includes epistaxis, gastrointestinal hemorrhage, hematuria, injection site hemorrhage, rectal hemorrhage, subarachnoid hemorrhage, subdural hematoma and other related terms. 10 1.5 9 2 Clinically relevant adverse reactions in <10% of patients who received ZENBEXUS (in combination with daratumumab and hyaluronidase-fihj and dexamethasone) included: • Venous thromboembolic event (includes retinal vein occlusion, pulmonary embolism, deep vein thrombosis, embolism venous, post thrombotic syndrome, superficial vein thrombosis, and thrombophlebitis). • Arterial thromboembolic event (includes myocardial infarction, stress cardiomyopathy, ischemic stroke, lacunar infarction, peripheral arterial occlusive disease). • Second primary malignancy • Febrile neutropenia • Sepsis • Hepatotoxicity Table 3: Select Laboratory Abnormalities (≥30%) That Worsened from Baseline The denominator used to calculate the rate varied from 201 to 204 for both IberDd and DVd arms based on the number of patients with a baseline value and at least one post-treatment value. in Patients Who Received ZENBEXUS in EXCALIBER-RRMM Laboratory Abnormality ZENBEXUS + Daratumumab and hyaluronidase-fihj + Dexamethasone (IberDd) Daratumumab and hyaluronidase-fihj + Bortezomib + Dexamethasone (DVd) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Hematology Neutrophil count decreased 97 77 48 11 White blood cell count decreased 95 69 64 18 Lymphocytes count decreased 91 62 81 51 Platelet count decreased 62 9 92 46 Hemoglobin decreased 58 6 63 6 Chemistry Blood calcium decreased 44 2 28 1 Blood alkaline phosphatase increased 33 0.5 26 0.5

<table width="100%"><caption>Table 2: Adverse Reactions (&#x2265;10%) in Patients Who Received ZENBEXUS in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone in EXCALIBER-RRMM</caption><col width="30%"/><col width="17%"/><col width="17%"/><col width="18%"/><col width="18%"/><tfoot><tr><td align="left" colspan="5" valign="top">Adverse reactions were graded according to NCI CTCAE Version 5.0.</td></tr></tfoot><tbody><tr><td rowspan="2" styleCode="Rrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">ZENBEXUS + Daratumumab and Hyaluronidase-fihj + Dexamethasone (IberDd) (n=204)</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Daratumumab and Hyaluronidase-fihj + Bortezomib + Dexamethasone (DVd) (n=204)</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">All Grades (%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Grade 3 or 4 (%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">All Grades (%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Grade 3 or 4 (%)</content></paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Infections and infestations</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Upper respiratory tract infection<footnote ID="_Ref237023399">Upper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection, sinusitis, and other related terms.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>54<footnote ID="_Ref237023407">Includes fatal adverse reaction: IberDd (n=1).</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>52</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>6</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Pneumonia<footnote ID="_Ref237023472">Pneumonia includes atypical pneumonia, bacterial pneumonia, lower respiratory tract infection, lung consolidation, viral pneumonia and other related terms.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>34</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>25</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>10</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> COVID-19<footnote ID="_Ref237023483">Includes other related terms.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>23</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>3.9</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>16</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>2.9</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">General disorders and administration site conditions</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Fatigue<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>36</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>3.4</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>33</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>2.5</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Edema<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.5</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>24</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Pyrexia</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>14</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Musculoskeletal and connective tissue disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Musculoskeletal pain<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>35</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1.5</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>33</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>2.9</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Bone pain<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.5</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Gastrointestinal disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Diarrhea<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>33</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>4.9</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>36</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>6</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Constipation</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>20</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>22</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Nausea</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>14</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.5</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Nervous system disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Motor dysfunction<footnote ID="_Ref237023530">Motor dysfunction includes ataxia, balance disorder, gait disturbance, muscle contracture, muscle spasms, muscular weakness, myopathy, paralysis, peripheral motor neuropathy and other related terms.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>26</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1.5</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>2.5</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Sensory neuropathy<footnote ID="_Ref237023542">Sensory neuropathy includes anosmia, hypoesthesia, mononeuropathy, neuralgia, paresthesia, peripheral neuropathy, peripheral sensory neuropathy, polyneuropathy, radiculopathy and other related terms.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>4.4</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>53</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>6</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Dizziness<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.5</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Skin and subcutaneous tissue disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Rash<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>26</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.5</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Psychiatric disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Sleep disorder<footnote ID="_Ref237023570">Sleep disorder includes insomnia, restless legs syndrome, sleep disorder and other related terms.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>25</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>2.9</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1.5</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Immune system disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Hypogammaglobulinemia<footnote ID="_Ref237023578">Hypogammaglobulinemia includes hypogammaglobulinemia, hypoglobulinemia, and other related terms.</footnote></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>24</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>12</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.5</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Cough<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.5</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>14</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0.5</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Dyspnea<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>10</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>0</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Renal and urinary disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Renal impairment<footnoteRef IDREF="_Ref237023483"/></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>3.4</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>3.9</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Vascular disorders</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph> Hemorrhage<footnote ID="_Ref237023608">Hemorrhage includes epistaxis, gastrointestinal hemorrhage, hematuria, injection site hemorrhage, rectal hemorrhage, subarachnoid hemorrhage, subdural hematoma and other related terms.</footnote></paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>10</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>1.5</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>2</paragraph></td></tr></tbody></table>

<table width="100%"><caption>Table 3: Select Laboratory Abnormalities (&#x2265;30%) That Worsened from Baseline<footnote ID="_Ref237023782">The denominator used to calculate the rate varied from 201 to 204 for both IberDd and DVd arms based on the number of patients with a baseline value and at least one post-treatment value.</footnote> in Patients Who Received ZENBEXUS in EXCALIBER-RRMM</caption><col width="36%"/><col width="16%"/><col width="16%"/><col width="16%"/><col width="16%"/><tbody><tr><td rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Laboratory Abnormality</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">ZENBEXUS + Daratumumab and hyaluronidase-fihj + Dexamethasone (IberDd)</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph><content styleCode="bold">Daratumumab and hyaluronidase-fihj + Bortezomib + Dexamethasone (DVd)</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">All Grades (%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Grade 3 or 4 (%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">All Grades (%)</content></paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Grade 3 or 4 (%)</content></paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Hematology</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Neutrophil count decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>97</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>77</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>48</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>11</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> White blood cell count decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>95</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>69</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>64</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>18</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Lymphocytes count decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>91</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>62</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>81</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>51</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Platelet count decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>62</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>92</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>46</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Hemoglobin decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>58</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>63</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>6</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph><content styleCode="bold">Chemistry</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph> Blood calcium decreased</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>44</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>2</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="middle"><paragraph>1</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph> Blood alkaline phosphatase increased</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>33</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>0.5</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>26</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="middle"><paragraph>0.5</paragraph></td></tr></tbody></table>