US FDA accepts priority review for EMD Serono's application for avelumab

The US Food and Drug Administration (FDA) has accepted priority review for EMD Serono's biologics licence application (BLA) for avelumab to treat patients with locally advanced or metastatic urothelial carcinoma (mUC).

EMD Serono is the biopharmaceutical business of German-based Merck.

A prescription drug user fee act (PDUFA) target action date of 27 August this year has been set by the FDA for avelumab in this indication. Avelumab is an investigational, fully human, anti-PD-L1 antibody.

Merck biopharma business, research and development global head and executive vice-president 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.

"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."

"We continue to evaluate avelumab in cancers that have limited or sub-optimal 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."

Bladder cancer makes up about 90% of urothelial cancers and is the sixth most common cancer in the US.

With the FDA's priority review status, the review time will reduce from ten months to a goal of six months from the day of filing acceptance.

In November last year, the agency accepted and granted priority review status to the BLA for avelumab to treat patients with metastatic Merkel cell carcinoma.

Urothelial Carcinoma includes several tumours originating from cells lining the bladder, renal pelvis and urethra.