publication date: Mar. 24, 2017

Drugs and Targets Bavencio receives accelerated approval for Merkel cell carcinoma

FDA granted an accelerated approval to Bavencio (avelumab) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma.

The agent is sponsored by EMD Serono Inc., a biopharmaceutical business of Merck KGaA and Pfizer Inc.

Avelumab is a programmed death-ligand 1 blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.

Approval was based on data from an open-label, single-arm, multi-center clinical trial (JAVELIN Merkel 200 trial) demonstrating a clinically meaningful and durable overall response rate (ORR).

All patients had histologically confirmed metastatic MCC with disease progression on or after chemotherapy administered for metastatic disease.

ORR was assessed by an independent review committee according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The ORR was 33% (95% confidence interval [CI]: 23.3, 43.8), with 11% complete and 22% partial response rates.

Among the 29 responding patients, the response duration ranged from 2.8 to 23.3+ months with 86% of responses durable for 6 months or longer. Responses were observed in patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus.

Safety data were evaluated in 1,738 patients who … Continue reading Bavencio receives accelerated approval for Merkel cell carcinoma

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