One application is for use of Keytruda (pembrolizumab) 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 14 June.
Merck Research Laboratories senior vice president and oncology late-stage development therapeutic area head Roger Dansey said: “Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer.
“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.”
Earlier, Keytruda had secured the Breakthrough Therapy Designation from the FDA for its use as a second-line option for treating patients having urothelial cancer in locally advanced or metastatic stages and whose disease had progressed on or after platinum-based chemotherapy.
A humanized monoclonal antibody, Keytruda is said to be undergoing evaluation in more than 30 types of tumors in over 400 clinical trials. As per Merck, at least half of the trials combine the antibody with other cancer therapies.
Image: Keytruda (pembrolizumab) Injection 100 mg. Photo: courtesy of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.