The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.
The FDA has provided full approval for Keytruda (pembrolizumab) for first-line advanced urothelial carcinoma. Previously, Keytruda was given accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy or for patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
The indication on the label has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.
In April 2021, the FDA’s Oncologic Drugs Advisory Committee voted 5-3 in favor of maintaining the indication in urothelial cancer despite the fact that the confirmatory phase 3 trial did not meet the dual primary end points of overall survival or progression-free survival. Panelists who voted for keeping the indication suggested that because Keytruda is active as a second-line treatment for patients with platinum-refractory urothelial carcinoma, it could be argued that it is active in the second-line setting.
“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, M.D., vice president, clinical research, Merck Research Laboratories, 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.”
Keytruda is also approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. It is also approved for the 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 cystectomy.
The PD-1 therapy is also approved for other cancers, including melanoma, nonsmall cell lung cancer, head and neck squamous cell cancer, Hodgkin lymphoma, large B-cell lymphoma, colorectal cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and renal cell carcinoma.