FDA Grants Priority Review to Avelumab for Urothelial Carcinoma

The U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression on or after platinum-based chemotherapy, according to an announcement by EMD Serono and Pfizer.¹

The BLA is based on preliminary data from the phase 1b JAVELIN Solid Tumor trial (ClinicalTrials.gov Identifier: NCT01772004), which evaluated the activity and safety of avelumab in 241 patients with metastatic urothelial carcinoma who progressed after platinum-based therapy or who were ineligible to receive cisplatin.

As of March 19, 2016, 17.6% (95% CI, 12.0-24.6) of the 153 evaluable patients achieved a confirmed objective response, including 9 complete and 18 partial responses. Nearly 90% of responses were ongoing, with the median duration of response not reached.

Median progression-free survival and overall survival were 6.4 weeks (95% CI, 6.1-11.4) and 7.0 months (95% CI, 5.6-11.1), respectively. The most common treatment-related adverse events were infusion-related reactions and fatigue.

The FDA is expected to take action on this application by August 27, 2017.

Avelumab is an investigational, fully humanized PD-L1-blocking monoclonal antibody. In November 2016, the FDA granted Priority Review to the BLA for avelumab for the treatment of patients with metastatic Merkel cell carcinoma.

Reference

1. FDA accepts the Biologics License Application for avelumab for the treatment of metastatic urothelial carcinoma for Priority Review [news release]. Rockland, MA: EMD Serono; February 28, 2017. http://media.emdserono.com/2017-02-28-FDA-Accepts-the-Biologics-License-Application-for-Avelumab-for-the-Treatment-of-Metastatic-Urothelial-Carcinoma-for-Priority-Review. Accessed February 28, 2017.