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- 02/28/2017

Merck KGaA, Pfizer: FDA accepts for priority review BLA for Avelumab

Pharma Horizon

German drugmaker Merck KGaA and U.S. partner Pfizer have been granted Priority Review EMD Serono’s Biologics License Application (BLA) as they seek to widen the use of immunotherapy drug avelumab to include bladder cancer.

The U.S. Food and Drug Administration will review trial data for the drug against locally advanced or metastatic urothelial carcinoma (mUC) which has worsened despite chemotherapy, within six months instead of the usual 10.  The FDA has set a PDUFA target action date of August 27, 2017


Avelumab belongs to a new generation of biotech drugs that stop some tumors from hiding from the immune system, similar to Merck & Co’s Keytruda or Roche’s Tecentriq.

Merck KGaA and Pfizer previously won U.S. priority review status for avelumab’s use against a rare and aggressive form of skin cancer.


Source: Reuters