FDA Designates Avelumab Orphan Drug for Skin Cancer
Pfizer and Merck announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to the investigational cancer immunotherapy avelumab for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.
Avelumab is currently being evaluated in the Merkel 200 study, a multicenter, single-arm, open-label trial evaluating patients with metastatic MCC who have previously received at least one line of chemotherapy. The primary endpoint is objective response rate.
Additional studies from the JAVELIN clinical trial program are also evaluating avelumab for other cancer indications, which include treatment for non-small cell lung cancer (NSCLC), advanced renal cell carcinoma (RCC), and metastatic or locally advanced solid tumors.
Avelumab is a fully human monoclonal IgG1 antibody against programmed death-ligand 1 (anti-PD-L1).
For more information call (800) 438-1985 or visit Pfizer.com.