FDA grants full approval to Keytruda for urothelial carcinoma subset
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The FDA granted full approval to pembrolizumab for first-line treatment of certain patients with advanced urothelial carcinoma, according to the agent’s manufacturer.
The agency also approved a revised indication for pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, to include treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for platinum-containing chemotherapy.
“[Although] 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, MD, vice president of clinical research for Merck Research Laboratories, said in a company-issued press release. “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.”
Earlier this year, the FDA’s Oncologic Drugs Advisory Committee (ODAC) reviewed indications for several cancer drugs that received accelerated approval but subsequently failed to show clinical benefit in clinical trials.
In April, ODAC voted 5-3 to maintain the accelerated approval of pembrolizumab for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. The FDA based that approval, granted in 2017, on an objective response rate of 29% in the KEYNOTE-052 study. In 2018, that indication was restricted to patients whose tumors expressed PD-L1, or for patients who are not eligible for any platinum-containing therapy regardless of PD-L1 status.
The subsequent phase 3 KEYNOTE-361 trial, which evaluated pembrolizumab as monotherapy and in combination with chemotherapy among platinum-eligible patients with advanced or metastatic urothelial carcinoma, failed to confirm clinical benefit in the first-line setting.
In voting to maintain the approval, ODAC panel members noted the lack of therapies that otherwise would be available for patients ineligible for platinum-based chemotherapy.
Pembrolizumab also is approved for other subsets of patients with bladder cancer, as well as certain patients with melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, lymphoma, microsatellite instability-high or mismatch repair-deficient cancer, hepatocellular carcinoma and renal cell carcinoma, among other cancers.
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