Pfizer, Merck KGaA score a landmark FDA OK for checkpoint contender avelumab
Merck KGaA and Pfizer have done it.
The biopharma partners came away with their first FDA approval of the checkpoint inhibitor avelumab, making it the fourth drug in this category to make it to the market. They beat AstraZeneca, which will now angle for its first approval of durvalumab as the 5th checkpoint.
The FDA gave out its approval for Merkel cell carcinoma under an accelerated approval process. The therapy, the first for a rare form of skin cancer, has also been given breakthrough drug status. The drug is currently in 30 clinical programs as the two players look to wedge their way into a multibillion-dollar market for drugs that are gaining wide use in treating cancer.
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