Pfizer-Merck KGaA Skin Cancer Drug Bavencio Gets EU Approval

 | Sep 21, 2017 09:58PM ET

Pfizer Inc. (NYSE:PFE) and German partner Merck KGaA announced that their anti-PD-L1 monoclonal antibody, Bavencio (avelumab), has been granted marketing authorization in the EU as a monotherapy for treating adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. The company expects to make the drug commercially available in the EU along with Germany and the U.K. within the next month.

Notably, with this approval, the drug will now be marketed in the 28 countries of the EU including Norway, Liechtenstein and Iceland. It is the first approved immunotherapy in the EU for the given indication.

Bavencio received the FDA approval for mMCC in March. With the approval, the drug became the first immunotherapy option for the said cancer treatment. In May, Bavencio received the FDA approval for a second indication. The drug was approved for urothelial carcinoma, an aggressive disease with a high rate of recurrence. Also, earlier this month, the drug was granted with an approval in Switzerland for treatment of mMCC.

Pfizer’s shares are up 10.7% so far this year, comparing unfavorably with the 16.6% rally of the Original post

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