FDA.reportPublic FDA data

ZYNYZ

Product NDC
50881-006
11-digit product format
508810006
Labeler code
50881
Product ID
50881-006_4b5a0ce6-7f12-44aa-9b45-05188a37da9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
retifanlimab-dlwr
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Incyte Corporation
Application
BLA761334
Marketing category
BLA
Marketing start
2023-03-22
Substance
RETIFANLIMAB
Active strength
25 mg/mL
Pharmacologic classes
Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYNYZRETIFANLIMAB-DLWRIncyte Corporation109648d0-d30a-42fc-8273-39cb1540a7512026-05-18Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions ( 5.1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune‑mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, and immune‑mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue ZYNYZ and administer corticosteroids based on the severity of reaction. ( 2.2 ) Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue ZYNYZ based on severity of reaction. ( 2.2 , 5.2 ) Complications of Allogeneic HSCT: Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD‑1/PD‑L1–blocking antibody. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Severe and Fatal Immune-Mediated Adverse Reactions ZYNYZ is a monoclonal antibody that belongs to a class of drugs that binds to either the programmed death receptor-1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with the potential for breaking of peripheral tolerance and induction of immune-mediated adverse reactions. Important immune‑mediated adverse reactions listed under Warnings and Precautions may not be inclusive of all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PD-L1–blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1–blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1–blocking antibodies. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management of immune‐mediated ...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling. Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions ( 5.1 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.2 )] Complications of Allogeneic HSCT [see Warnings and Precautions ( 5.3 )] ZYNYZ in Combination with Carboplatin and Paclitaxel In patients with SCAC, the most common (≥ 20%) adverse reactions are fatigue, peripheral neuropathy, nausea, alopecia, diarrhea, musculoskeletal pain, constipation, hemorrhage, rash, vomiting, decreased appetite, pruritus, and abdominal pain. ( 6.1 ) ZYNYZ as a Single Agent In patients with SCAC, the most common (≥ 10%) adverse reactions are fatigue, musculoskeletal pain, diarrhea, non-urinary tract infections, perineal pain, hemorrhage, urinary tract infection, rash, nausea, decreased appetite, constipation, abdominal pain, dyspnea, pyrexia, vomiting, cough, pruritus, hypothyroidism, headache, and decreased weight. ( 6.1 ) In patients with MCC, the most common (≥ 10%) adverse reactions are musculoskeletal pain, fatigue, pruritus, diarrhea, rash, pyrexia, nausea, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial 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 practice. The safety population described in Warnings and Precautions reflects exposure to ZYNYZ 500 mg as an intravenous infusion every 4 weeks in combination with carboplatin and paclitaxel in 154 patients with SCAC enrolled in the POD1UM-303 trial, and as a single agent in 94 patients with SCAC in the POD1UM-202 trial, 107 patients with MCC in the POD1UM-201 trial, and 251 patients with other solid tumors. All patients received ZYNYZ until disease progression or unacceptable toxicity; those in the POD1UM-202 and POD1UM-201 trials received ZYNYZ for up to 24 months and those in the POD1UM-303 trial received ZYNYZ for up to 12 months. The median duration of exposure of the pooled monotherapy population was 5.4 months (range: 1 day to 27 months). Squamous Cell Carcinoma of the Anal Canal (SCAC...

adverse reactions table

Table 3: Adverse Reactions in ≥ 10% of Patients with Inoperable Locally Recurrent or Metastatic SCAC Receiving ZYNYZ in Combination with Carboplatin and Paclitaxel with a Difference Between Arms of ≥ 5% for All Grades or ≥ 2% for Grades 3 or 4 vs Placebo in Combination with Carboplatin and Paclitaxel in POD1UM-303 ZYNYZ in Combination with Carboplatin and Paclitaxel (N = 154) Placebo in Combination with Carboplatin and Paclitaxel (N = 152) Adverse Reaction All Grades (%)Grades 3-4 (%) All Grades (%)Grades 3-4 (%) Gastrointestinal disorders DiarrheaIncludes diarrhea, colitis, and frequent bowel movements. 49 5417StomatitisIncludes stomatitis, aphthous ulcer, cheilitis, mouth ulceration, and mucosal inflammation. 18 0110Nervous system disorders Peripheral neuropathyIncludes peripheral neuropathy, paresthesia, peripheral sensory neuropathy, neuralgia, hypoesthesia, peripheral sensorimotor neuropathy, dysesthesia, peripheral motor neuropathy, and hyperesthesia. 56 5522.6Musculoskeletal and connective tissue disorders Musculoskeletal painIncludes arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, non-cardiac chest pain, pain in extremity, and spinal pain. 40 2.6 34 0 Vascular disorders HemorrhageIncludes hemorrhage, anal hemorrhage, anal ulcer hemorrhage, conjunctival hemorrhage, epistaxis, gastrointestinal hemorrhage, genital hemorrhage, hematuria, hemoptysis, hemorrhoidal hemorrhage, lower gastrointestinal hemorrhage, lymph node hemorrhage, rectal hemorrhage, stoma site hemorrhage, tumor hemorrhage, urinary bladder hemorrhage, uterine hemorrhage, vaginal hemorrhage, and wound hemorrhage. 29 3.2 21 0 Skin and subcutaneous tissue disorders RashIncludes rash, eczema, dermatitis acneiform, dermatitis, rash erythematous, rash maculo-papular, rash papular, rash pustular, and rash pruritic.29 1.3 16 0.7 Pruritus 24 0.6 7 0 Endocrine disorders Hypothyroidism14 0.6 3.3 0 Graded according to NCI CTCAE v5.0.

Additional Listing Data#

Finished product
Yes
Brand name base
ZYNYZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RETIFANLIMAB25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2Y3T5IF01Z
Rxcui2632985, 2632991

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8b42fb54-811a-4a53-bb1e-10efdc21c87cProduct name120240419
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50881-006-03ZYNYZ1 in 1 CARTONINJECTION116
50881-006-03ZYNYZ20 mL in 1 VIAL, SINGLE-USEINJECTION2016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50881-006-03ML - Milliliter50881-0061083fdee-040e-432b-a9a6-11f456bb6ae812023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50881-006ZYNYZ (RETIFANLIMAB-DLWR) INJECTION [INCYTE CORPORATION]7Current NDC, 2 package rows20240418_109648d0-d30a-42fc-8273-39cb1540a751.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761334Zynyzretifanlimab-dlwr351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2632985retifanlimab-dlw 500 MG in 20 ML InjectionPSN109648d0-d30a-42fc-8273-39cb1540a75116
2632991ZYNYZ 500 MG in 20 ML InjectionPSN109648d0-d30a-42fc-8273-39cb1540a75116
263299120 ML retifanlimab-dlwr 25 MG/ML Injection [Zynyz]SBD109648d0-d30a-42fc-8273-39cb1540a75116
263298520 ML retifanlimab-dlwr 25 MG/ML InjectionSCD109648d0-d30a-42fc-8273-39cb1540a75116
263299120 ML Zynyz 25 MG/ML InjectionSY109648d0-d30a-42fc-8273-39cb1540a75116
2632985retifanlimab-dlw 500 MG per 20 ML InjectionSY109648d0-d30a-42fc-8273-39cb1540a75116
2632991Zynyz 500 MG per 20 ML InjectionSY109648d0-d30a-42fc-8273-39cb1540a75116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50881-006-03508810006031 VIAL, SINGLE-USE in 1 CARTON (50881-006-03) / 20 mL in 1 VIAL, SINGLE-USE2023-03-22NoNoCurrent