Approval for the pd-l1 ihc 22c3 pharmdx. Pd-l1 ihc 22c3 pharmdx is a qualitative immunohistochemical assay using monoclonal mouse anti-pd-l1, clone 22c3 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-small cell lung cancer (nsclc), gastric or gastroesophageal junction (gej) adenocarcinoma, esophageal squamous cell carcinoma (escc), cervical cancer, urothelial carcinoma and head and neck squamous cell carcinoma (hnscc) tissues using envision flex visualization system on autostainer link 48. Pd-l1 protein expression in nsclc is determined by using tumor proportion score (tps), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. Pd-l1 protein expression in gastric or gej adenocarcinoma, escc, cervical cancer, urothelial carcinoma and hnscc is determined by using combined positive score (cps), which is the number of pd-l1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. Companion diagnostic indicationstumor indication pd-l1 expression level intended usensclc tps greater than or equal to 1% pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying nsclc patients for treatment with keytruda® (pembrolizumab). **gastric or gej adenocarcinoma cps greater than or equal to 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying gastric or gej adenocarcinoma patients for treatment with keytruda® (pembrolizumab). Escc cps greater than or equal to 10 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying esophageal squamous cell cancer patients for treatment with keytruda® (pembrolizumab). Cervical cancer cps greater than or equal to 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying cervical cancer patients for treatment with keytruda® (pembrolizumab). Urothelial carcinoma cps greater than or equal to 10 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying urothelial carcinoma patients for treatment with keytruda® (pembrolizumab). **hnscc cps 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying hnscc patients for treatment with keytruda® (pembrolizumab). ****see the keytruda® product label for specific clinical circumstances guiding pd-l1 testing. For in vitro diagnostic use.
| Device | PD-L1 IHC 22C3 pharmDx |
| Classification Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | DAKO NORTH AMERICA, INC. |
| Date Received | 2019-02-25 |
| Decision Date | 2019-07-30 |
| PMA | P150013 |
| Supplement | S016 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150013 | | Original Filing |
| S025 |
2022-08-08 |
Real-time Process |
| S024 |
2022-01-31 |
Special (immediate Track) |
| S023 |
2021-11-17 |
Special (immediate Track) |
| S022 | | |
| S021 |
2020-08-31 |
Normal 180 Day Track |
| S020 |
2020-06-29 |
Panel Track |
| S019 |
2020-02-06 |
Normal 180 Day Track No User Fee |
| S018 |
2019-09-05 |
Normal 180 Day Track No User Fee |
| S017 |
2019-06-14 |
Normal 180 Day Track |
| S016 |
2019-02-25 |
Panel Track |
| S015 |
2019-02-15 |
30-day Notice |
| S014 | | |
| S013 |
2018-12-21 |
30-day Notice |
| S012 | | |
| S011 |
2018-06-25 |
Panel Track |
| S010 |
2018-03-12 |
30-day Notice |
| S009 |
2018-01-29 |
Panel Track |
| S008 |
2017-12-26 |
30-day Notice |
| S007 |
2017-09-21 |
Normal 180 Day Track No User Fee |
| S006 |
2017-04-19 |
Panel Track |
| S005 |
2017-04-17 |
30-day Notice |
| S004 |
2016-12-27 |
Real-time Process |
| S003 |
2016-08-19 |
Real-time Process |
| S002 |
2016-06-28 |
Real-time Process |
| S001 |
2015-12-31 |
Panel Track |
NIH GUDID Devices