A panel of outside advisers to the U.S. Food and Drug Administration voted 9 to 4 in favor of approving Merck & Co. Inc.'s blockbuster drug, Keytruda, for the treatment of high-risk, non-muscle invasive bladder cancer.
Keytruda, or pembrolizumab, is a checkpoint inhibitor — a tumor-targeting drug that blocks the PD-1 arm on healthy cells from linking up with a partner arm on the surface of cancer cells to spread the disease. The drug is already approved in the U.S. in multiple cancer indications.
During a Dec. 17 meeting, the majority of the Oncologic Drugs Advisory Committee voted that Keytruda, which is under a priority review by the FDA for treatment of high-risk, non-muscle invasive bladder cancer that has carcinoma in-situ, has the potential to treat the disease in patients who have limited nonsurgical treatment options.
Initial results from a phase 2 study, dubbed Keynote-057, showed that 38.8% of bladder cancer patients who received Keytruda in a mid-stage trial had no detectable cancer at three months.
According to Merck & Co.'s Dec. 17 press release, more than 80,000 new cases of bladder cancer will be diagnosed in 2019 in the U.S. and about 75% of bladder cancer patients have non-muscle invasive bladder cancer.
The FDA is set to decide on Keytruda's additional approval in January 2020. The U.S. regulator is not required to take the advisory committee's recommendation.