The FDA has upgraded pembrolizumab’s accelerated approval for urothelial carcinoma to a full approval, allowing the drug to be used in patients with locally advanced or metastatic disease who are not eligible for platinum-containing chemotherapy.
Previously, this drug was authorized to treat locally advanced or metastatic urothelial carcinoma in patients who were not canditates for cisplatin-containing chemotherapy and whose tumors expressed PD-L1 (Combined Positive Score ≥10), as determined by an FDA-approved test, or patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
“This indication was approved under accelerated approval based on tumor response rate and duration of response,” the drug’s manufacturer, Merck, wrote in a company press release. “Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. The subsequent Phase III trial KEYNOTE-361, evaluating [pembrolizumab] as monotherapy and in combination with chemotherapy for the first-line treatment of patients with advanced or mUC who were eligible for platinum-containing chemotherapy, did not meet its pre-specified dual primary endpoints of overall survival or progression-free survival, compared with standard of care chemotherapy.”
In addition to this indication, pembrolizumab is also approved to treat urothelial carcinoma patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In addition, the drug is also approved for 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 or unwilling to undergo cystectomy.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 120
Topic ID: 78,120,730,120,935,192,725,925
