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Merck Wins FDA Nod for Combo Therapy in Advanced Kidney Cancer

Xconomy New York — 

Merck’s blockbuster immunotherapy has notched FDA approval for treating the most serious cases of kidney cancer.

The FDA on Monday approved Merck (NYSE: MRK) drug pembrolizumab (Keytruda) in combination with Pfizer (NYSE: PFE) drug axitinib (Inlyta) as a first-line treatment for advanced renal call carcinoma—kidney cancer that has spread or grown, despite earlier treatments.

Pembrolizumab’s previous approvals include lung, skin, cervical, and gastric cancers. The latest FDA nod marks the first for the Merck drug in advanced renal cell carcinoma. The decision now puts the Merck drug in competition with a Bristol-Myers Squibb (NYSE: BMY) immunotherapy, nivolumab (Opdivo), which had previously been approved for advanced kidney cancer.

The Merck drug blocks a cancer protein called PD1, which some cancers use to evade detection by the immune system. The Merck drug and Pfizer’s axitinib were tested in a Phase 3 study that compared the combination to treatment with sunitinib (Sutent), a Pfizer drug that is the standard of care for kidney cancer. Merck had reported that patients treated with the combination therapy lived longer and their cancers stayed in remission longer, the main goals of the study.

Other companies are also vying to treat kidney cancer with combination therapies. Last fall, Merck KGaA of Germany, which is a different company than Kenilworth, NJ-based Merck, and Pfizer reported encouraging data from Phase 3 tests of their drugs avelumab and axitinib in previously untreated kidney cancer.

Public domain image of renal cell carcinoma by the CDC