Tag Archives: MCC

December, 2018

20 December
FDA Approves Merck’s Keytruda for Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the …
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23 March
FDA Grants Accelerated Approval to Bavencio, the First Treatment for Rare Form of Skin Cancer

The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, …
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20 March
FDA Grants Orphan Drug Status to NantKwest’s Merkel Cell Carcinoma Candidate

CULVER CITY, Calif.–(BUSINESS WIRE)–NantKwest, Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, announced today that the FDA has granted Orphan Drug Designation to the company’s activated …
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30 November
FDA Grants Priority Review to Avelumab for Treatment of Merkel Cell Carcinoma

EMD Serono Inc., the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review EMD Serono’s Biologics License Application (BLA) for avelumab. This review relates to avelumab’s proposed …
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18 November
Pfizer and Merck KGaA’s MCC Drug Receives Breakthrough Therapy Designation

Merck KGaA, Darmstadt, Germany, and Pfizer today announced that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy …
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7 October
FDA Grants Fast Track Status to Merck and Pfizer’s Rare Skin Cancer Drug

DARMSTADT, Germany & NEW YORK–(BUSINESS WIRE)–Merck KGaA, Darmstadt, Germany, and Pfizer today announced that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of …
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