Pfizer immuno-oncology drug wins U.S. approval for bladder cancer

U.S. health regulators on Tuesday granted accelerated approval for Pfizer Inc's immuno-oncology drug Bavencio to treat advanced bladder cancer, marking the second approval in less than two months for the treatment developed along with Germany's Merck KGaA.

Bavencio, known chemically as avelumab, was approved for patients with locally advanced or metastatic bladder cancer whose disease progressed during or following platinum-containing chemotherapy or within 12 months of chemotherapy treatment before or after surgery. It is the fourth new immunotherapy to be approved for advanced bladder cancer.

In March, Bavencio was approved by the Food and Drug Administration to treat a rare skin cancer called Merkel cell carcinoma.

German Merck said the wholesale price for Bavencio based on an average bladder cancer patient will be about $13,000 a month, less than the $15,000 per month AstraZeneca set after its Imfinzi received U.S. approval for bladder cancer a week ago. Roche's Tecentriq and Opdivo from Bristol-Myers Squibb are also approved for bladder cancer.

The Bavencio approval was based on response rates from a study of 242 patients who all received Bavencio. As a condition of accelerated approval, the companies will conduct another trial to confirm that it can extend survival.

Bavencio belongs to a class of drugs called PD-L1 or PD-1 inhibitors that help the immune system to attack cancer by blocking a mechanism tumors use to evade detection.

(Reporting by Bill Berkrot; Editing by James Dalgleish and Richard Chang)

Tue May 9, 2017



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