FDA Accepts Merck-Pfizer Biologics Application

In the course of only a week, the US Food and Drug Administration FDA) has accepted the second Biologics License Application (BLA) for priority review. In the latest case, the candidate is avelumab, an investigational, fully human anti-PD-L1 antibody drug recommended for treatment of patients for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy.

The application was filed by EMD Serono, the North American arm of German pharmaceuticals and chemicals group Merck KGaA, which is launching the drug in cooperation with US pharmaceuticals major Pfizer.  The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 27 this year for avelumab in this indication. In November 2016, the US regulatory authority accepted and granted priority review status to avelumab for treatment of patients with metastatic Merkel cell carcinoma.

The international clinical development program for avelumab, which is known as JAVELIN, involves at least 30 clinical programs. This includes nine Phase 3 trials, and more than 4,000 patients evaluated across more than 15 tumor types. One of the trials is currently enrolling patients.

“Taken together with last year’s filing for metastatic Merkel cell carcinoma, this BLA acceptance confirms our rapid and continued progress in the clinical development of avelumab,” said Luciano Rossetti, global head of research & development at the biopharma business of Merck KGaA. “We continue to evaluate avelumab in cancers that have limited or suboptimal treatment choices, such as metastatic or locally advanced urothelial carcinoma, to hopefully be able to provide patients with new treatment options for fighting their disease,” he said.

The FDA’s priority review status reduces the review time from 10 months to a goal of six months from the day of filing acceptance and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. The prognosis for advanced or metastatic urothelial carcinoma is generally poor.