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FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma


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On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label update, this indication 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.

Previously, pembrolizumab was indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed PD-L1 (combined positive score [CPS] ≥ 10) as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication received an accelerated approval based on tumor response rate and duration of response.

Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. The subsequent phase III KEYNOTE-361 trial, evaluating pembrolizumab as monotherapy and in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic urothelial carcinoma who were eligible for platinum-containing chemotherapy, did not meet its prespecified dual primary endpoints of overall and progression-free survival compared with standard-of-care chemotherapy.

Industry-Wide Evaluation

This label update follows the FDA’s Oncologic Drugs Advisory Committee meetings held earlier this year as part of an industry-wide evaluation of indications based on accelerated approvals that have not met their postmarketing requirements. As previously announced, members voted 5 to 3 in favor of maintaining the accelerated approval of pembrolizumab for its first-line bladder cancer indication.

In addition to this first-line indication, pembrolizumab is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Pembrolizumab 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.


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