Pfizer, Merck KGaA grab EU approval for PD-L1 Bavencio in Merkel cell carcinoma

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Bavencio, the new immuno-oncology drug from Merck KGaA and Pfizer, has won an approval in Europe to treat the aggressive skin cancer Merkel cell carcinoma.

Pfizer and Merck KGaA’s new immuno-oncology drug Bavencio, which won an FDA nod for Merkel cell carcinoma in March, is now approved in Europe to treat the aggressive type of skin cancer.

The partners today said that they expect to first launch Bavencio the U.K. and Germany after the European Commission approved Bavencio to treat often fatal cancer, which hits about 2,500 Europeans, with as many as 12% diagnosed with metastatic disease.  

“Merkel cell carcinoma is a particularly aggressive form of skin cancer with very poor outcomes, especially for those with metastatic disease," Dr. Dirk Schadendorf, director of dermatology at University Hospital Essen, Germany, said in a statement issued by Pfizer and Merck. "This approval is a meaningful development for patients and their families suffering from this devastating disease."

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Pfizer and Merck pointed out that Bavencio is the first immuno-oncology drug approved in the EU to treat the disease. Bavencio belongs to a class of drugs called PD-L1 or PD-1 inhibitors that help the immune system attack cancer by blocking a mechanism tumors use to evade detection.

In addition to its Merkel cell approval in the U.S., Bavencio has been approved by the FDA to treat bladder cancer. Bavencio approvals add to Pfizer’s stable, where CDK4/6 inhibitor Ibrance now ranks as a fast-growing med. Its approval was particularly key to Merck, which hasn’t seen a new drug approval in more than 10 years and expected to get up to $2 billion in regulatory and commercial milestone payments from Pfizer.

With its foot in the PD-1/PD-L1 door, Bavencio now finds itself competing with a host of new immuno-oncology drugs. In bladder cancer, it is up against AstraZeneca’s Imfinzi and Tecentriq from Roche as well as Bristol-Myers Squibb’s Opdivo and Keytruda from U.S.-based Merck & Co.  

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Each of these meds has a set of indications in various cancers, with Opdivo and Keytruda, as the first two out of the gate, boasting the longest lists, including nods in melanoma, lung cancer and head and neck cancer.