FDA accepts BLA for avelumab for treating metastatic Merkel cell carcinoma

The FDA has accepted for priority review EMD Sorono’s biologics license application for avelumab in the treatment of patients with metastatic Merkel Cell carcinoma, according to a press release.

The review is based on tumor response results from the JAVELIN Merkel 200 trial of avelumab, a fully human anti-PDlL1 igG1 monoclonal antibody, according to a release from Pfizer and EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. If approved, avelumab would be the first treatment indicated for metastatic Merkel Cell Carcinoma (MCC).

JAVELIN Merkel 200 was a multicenter, open-label phase 2 study of 88 patients with metastatic MCC, whose disease had progressed after at least one chemotherapy treatment.

The priority review status reduces review time from 10 months to a goal of six months and is given to drugs that may offer major advances in treatment or provide treatment where no adequate therapy exists, according to the release.

“Metastatic [MCC] is an aggressive disease, and patients face a very poor prognosis, with less than 20 percent surviving beyond five years,” Chris Boshoff, MD, PhD, senior vice president and head of immune-oncology, early development and translational oncology, Pfizer Global Product Development, stated in the release. “We are encouraged by the results of our phase 2 trial and believe avelumab may have potential to be an important option for patients with this hard-to-treat skin cancer.”

Reference: www.emdserono.com; www.pfizer.com