As Merck received its latest FDA nod for Keytruda in ovarian cancer, Agilent gained the green light for its accompanying test to identify patients who can best benefit from the drug.
The test, PD-L1 IHC 22C3 pharmDx, becomes the only FDA-approved companion diagnostic to help find patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma, whose tumors express PD-L1 and who could therefore benefit from Keytruda.
Merck’s drug gained a license for this indication Feb. 10, adding to a long and growing list of oncology uses for the megablockbuster.
This approval also marks the seventh FDA-approved companion use for Agilent’s diagnostic to identify patients who can receive Keytruda.
The test allows pathologists to seek out PD-L1 expression when a patient is diagnosed and tap Keytruda if they qualify.
Last week, Merck reported 2025 sales of Keytruda at $31.7 billion, an increase of 7% year over year and 49% of the company’s total revenue.
