FDA grants priority review to Keytruda for two urothelial cancer indications

Issue: March 10, 2017

The FDA granted priority review to two supplemental biologics license applications that seek approval of pembrolizumab for the treatment of locally advanced or metastatic urothelial cancer.

One application is for use of pembrolizumab (Keytruda, Merck) — an anti–PD-1 monoclonal antibody — as first-line treatment of patients who are ineligible for cisplatin-containing therapy.

The other application is for use of pembrolizumab as second-line treatment for patients whose disease progressed on or after platinum-containing chemotherapy.

The FDA is expected to make decisions on the applications by June 14.

“Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer,” Roger Dansey, MD, senior vice president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said in a company-issued press release. “The data with Keytruda administered to patients with advanced urothelial cancer are promising, and we look forward to working with the FDA throughout the review process with the goal of bringing Keytruda to patients who may benefit as quickly as possible.”

The FDA previously granted breakthrough therapy designation to pembrolizumab as a second-line treatment for patients with locally advanced or metastatic urothelial cancer whose disease progressed on or after platinum-containing chemotherapy.

Pembrolizumab is approved for treatment of unresectable or metastatic melanoma; first-line treatment of patients with metastatic non–small cell lung cancer whose tumors have high PD-L1 expression but do not have EGFR or ALK genomic tumor aberrations; patients with metastatic, PD-L1–expressing NSCLC that progressed on or after platinum-containing chemotherapy; and patients with recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy.