German Merck, Pfizer get FDA priority review for cancer drug

German Merck, Pfizer get FDA priority review for cancer drug

German drugmaker Merck KGaA and USA partner Pfizer have been granted priority review status in the United States as they seek approval to fight a rare and aggressive form of skin cancer with immunotherapy drug avelumab.

"There are now no approved treatment options for metastatic MCC, and we are committed to working with the FDA to potentially bring the first approved cancer immunotherapy to patients with this aggressive disease". About avelumab Avelumab is a fully human anti-PD-L1 IgG1 monoclonal antibody. 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.

By inhibiting PD-L1 interactions, 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). An objective response was achieved in 28 patients (32%), including eight complete responses and 20 partial responses. After a follow-up of 10.4 months, 82% of patients continued to respond to therapy. The results from this study were published in Lancet Oncology in October 2016. (PFE) announced that the US Food and Drug Administration has accepted for Priority Review EMD Serono's Biologics License Application or BLA for avelumab. The FDA previously granted avelumab an orphan drug designation for MCC, as well as fast track and breakthrough therapy designations for the treatment of patients with metastatic MCC whose disease had progressed after at least one previous chemotherapy regimen. MCC most often develops in older people.

EMD Serono is the biopharmaceutical business of Merck in the U.S. and Canada.