Merck and Pfizer announced that the Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for avelumab to treat metastatic Merkel cell carcinoma.

The BLA submission proposed the use of avelumab in patients with metastatic Merkel cell carcinoma (MCC) based on tumor response data from the JAVELIN Merkel 200 trial. The Phase 2 multicenter, single-arm, open-label study (n=88) included patients with metastatic MCC with disease progression after at least one chemotherapy treatment. Full findings were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) and published in Lancet Oncology.

The JAVELIN clinical development program includes at least 30 clinical programs and over 3,000 patients across more than 15 different tumor types. 

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Avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, can potentially be the first treatment approved for metastatic MCC in the U.S. if approved. Through PD-L1 inhibition, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to potentially engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC).

Avelumab was granted Orphan Drug Designation for MCC, as well as Fast Track and Breakthrough Therapy Designations for this condition. 

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