This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval application (pma) supplement submitted to update the current approved urothelial carcinoma (uc) indication of pd-l1 ihc 28-8 pharmdx: to include enhanced disease-free survival and new clinical data from bristol-myers squibb (bms) clinical study ca209274 (checkmate-274) in this existing indication. Pd-l1 ihc 28-8 pharmdx is a qualitative immunohistochemical assay using monoclonal rabbit anti-pd-l1, clone 28-8 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-small cell lung cancer (nsclc), squamous cell carcinoma of the head and neck (scchn), and urothelial carcinoma (uc) tissues using envision flex visualization system on autostainer link 48. Pd-l1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. Companion diagnostic indicationtumor indication pd-l1 expressionclinical cutoff intended usensclc? 1% tumor cell expression pd-l1 ich 28-8 pharmdx is indicated as an aid in identifying nsclc patients for treatment with opdivo (nivolumab) in combination with yervoy (ipilimumab). When used in accordance with approved therapeutic labeling:pd-l1 expression (? 1% or? 5% or? 10% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in non-squamous nsclc (nsnsclc) may be associated with enhanced survival from opdivo. Pd-l1 expression (? 1% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in scchn may be associated with enhanced survival from opdivo. Pd-l1 expression (? 1% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in uc may be associated with enhanced response rate and enhanced disease-free survival from opdivo®. See the opdivo® and yervoy® product labels for specific clinical circumstances guiding pd-l1 testing.
| Device | PD-L1 IHC 28-8 pharmDx |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | Agilent Technologies, Inc. |
| Date Received | 2021-07-12 |
| Decision Date | 2021-10-18 |
| PMA | P150025 |
| Supplement | S014 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Agilent Technologies, Inc. 5301 Stevens Creek Blvd santa Clara, CA 95051 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150025 | Original Filing | |
| S015 | 2022-06-17 | 30-day Notice |
| S014 | 2021-07-12 | Normal 180 Day Track |
| S013 | 2019-12-16 | Panel Track |
| S012 | ||
| S011 | 2019-02-15 | 30-day Notice |
| S010 | 2018-12-21 | 30-day Notice |
| S009 | 2018-03-12 | 30-day Notice |
| S008 | 2017-12-26 | 30-day Notice |
| S007 | ||
| S006 | 2017-04-17 | 30-day Notice |
| S005 | 2016-12-29 | Normal 180 Day Track No User Fee |
| S004 | 2016-12-27 | Real-time Process |
| S003 | 2016-12-22 | Panel Track |
| S002 | 2016-08-19 | Real-time Process |
| S001 | 2016-07-07 | Real-time Process |