Approval for the pd-l1 ihc 22c3 pharmdx. The device 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, cervical cancer and urothelial carcinoma tissues using envision flex visualization system on autostainer link 48. Non-small cell lung cancer (nsclc)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. The specimen should be considered to have pd-l1 expression if tps >= 1% and high pd-l1 expression if tps >= 50%. Pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying nsclc patients for treatment with keytruda® (pembrolizumab). See the keytruda® product label for expression cutoff values guiding therapy in specific clinical circumstances. Gastric or gastroesophageal junction (gej) adenocarcinoma pd-l1 protein expression in gastric or gej adenocarcinoma 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. The specimen should be considered to have pd-l1 expression if cps >= 1. Pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying gastric or gej adenocarcinoma patients for treatment with keytruda® (pembrolizumab). Cervical cancer pd-l1 protein expression in cervical cancer 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. The specimen should be considered to have pd-l1 expression if cps >= 1. Pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying cervical cancer patients for treatment with keytruda® (pembrolizumab). Urothelial carcinomapd-l1 protein expression in urothelial carcinoma 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. The specimen should be considered to have pd-l1 expression if cps >= 10. Pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying urothelial carcinoma patients for treatment with keytruda® (pembrolizumab). See the keytruda® product label for specific clinical circumstances guiding pd-l1 testing.
| 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 | 2018-06-25 |
| Decision Date | 2018-08-16 |
| Notice Date | 2018-08-20 |
| PMA | P150013 |
| Supplement | S011 |
| Product Code | PLS |
| Docket Number | 18M-3212 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| 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