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FDA grants priority review for EMD Serono's avelumab for metastatic urothelial carcinoma

PBR Staff Writer Published 01 March 2017

The US Food and Drug Administration (FDA) has granted priority review for EMD Serono's biologics license application (BLA) of avelumab to treat metastatic urothelial carcinoma (mUC).

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

The BLA has been accepted for Merck and Pfizer's avelumab to treat patients with locally advanced or mUC with disease progression on or after platinum-based therapy.

Avelumab is an investigational and fully human anti-PD-L1 antibody. Last November, FDA also granted priority review for BLA of avelumab to treat patients with metastatic Merkel cell carcinoma.

Javelin, an international clinical development program for avelumab, includes around 30 clinical programs with nine Phase III trials. The program assessed about 4,000 patients across more than 15 tumor types.

In December 2015, Merck and Pfizer started a Phase III study (Javelin Bladder 100) of avelumab in the first-line setting as a maintenance treatment in patients with locally advanced or metastatic UC. The patients are currently being enrolled in this trial.

According to Merck, Avelumab is currently not received approval for any indication in any market.

Merck biopharma business’ research and development global head Luciano Rossetti said: “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.”

Pfizer global product development, early development and translational oncology and immuno-oncology head Dr Chris Boshoff said: “Advanced urothelial carcinoma remains a difficult-to-treat tumor, which is why we are developing a comprehensive clinical development program that involves Phase I and III trials designed to address this challenge.”


Image: Merck biopharma business’ research and development global head Luciano Rossetti. Photo: courtesy of Merck KGaA.