Labcorp Launches FDA-Approved Companion Diagnostic for KEYTRUDA in Platinum-Resistant Ovarian Cancer

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Labcorp announced nationwide availability of Agilent's PD-L1 IHC 22C3 pharmDx on April 22, 2026, the only FDA-approved companion diagnostic to identify patients with platinum-resistant ovarian cancer eligible for KEYTRUDA and KEYTRUDA QLEX.12

The FDA approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, in February 2026 for adults with PD-L1+ (CPS ≥1) platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after one or two prior treatments.1236

The test detects PD-L1 expression to aid in selecting patients for these therapies, addressing a need where ~80% of ovarian cancer patients recur and develop platinum resistance.12

Labcorp participated in Agilent's Early Validation Program for rapid rollout post-FDA approval.12

Clinical data from KEYNOTE-B96 trial showed improved progression-free and overall survival with KEYTRUDA combination vs. placebo.2

Sources:

1. https://www.stocktitan.net/news/LH/labcorp-launches-fda-approved-companion-diagnostic-to-identify-o7w9qp7nvych.html

2. https://www.labcorp.com/education-events/press-releases/labcorp-launches-fda-approved-companion-diagnostic-identify

3. https://www.investing.com/news/company-news/labcorp-launches-diagnostic-test-for-ovarian-cancer-treatment-93CH-4628794

6. https://www.ahdbonline.com/web-exclusives/fda-approvals/new-treatment-option-for-platinum-resistant-ovarian-cancer-patients