FDA extends full approval for Merck's Keytruda in 1st-line bladder cancer after mixed adcomm vote
Merck’s accelerated approval for Keytruda in first-line bladder cancer was one of a slate of early nods put under the microscope by an FDA advisory committee earlier this year after flopping confirmatory tests. Keytruda passed that test, and now the FDA is making its accelerated OK official.
The FDA on Tuesday gave its full approval to Keytruda as a treatment for first-line advanced bladder cancer patients who are not eligible for platinum-based chemo despite a confirmatory outcomes trial in an expanded patient population turning up a dud, Merck said in a statement.
Keytruda earned an accelerated nod in first-line locally advanced or metastatic urothelial cancer (UC) patients who were not eligible for chemo back in May 2017. But the confirmatory KEYNOTE-361 study, which aimed to expand Keytruda into patients who had been previously treated with platinum-based chemo, failed both of its key primary endpoints, effectively shutting down Keytruda’s broader use.
Earlier this year, Keytruda’s first-line approval in bladder cancer was one of the indications considered by an FDA adcomm for continued support. The adcomm voted 5-3 to maintain the accelerated approval. Meanwhile, three other indications reviewed at that meeting have since been withdrawn after further consultation with the FDA.
In a release, Merck chalked up the full approval to the continued lack of success for PD-1 immunotherapies in first-line patients, which Roche and AstraZeneca both having racked up losses:
“While the treatment landscape has evolved, an unmet need remains for appropriate patients newly diagnosed with certain types of advanced urothelial carcinoma who are not eligible for platinum-containing chemotherapy,” Scot Ebbinghaus, Merck Research Laboratories’ VP of clinical research said in a statement. “We are confident in the role Keytruda will continue to play for these patients who have few other treatment options and are working with urgency to advance studies to help more patients living with bladder and other types of cancer.”
Securing a full approval despite controversy could be seen as a win, but not for Keytruda, the world’s second-bestselling drug that has soaked up indications on its way to dominating the immune checkpoint inhibitor space.
In bladder cancer, in particular, Merck has taken an aggressive approach, securing approvals in UC patients whose disease progresses during or after platinum-based chemo or within 12 months of neoadjuvant or adjuvant chemo, and as a treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo a cystectomy.