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Pembrolizumab Receives Full FDA Approval for Certain Patients With Advanced Urothelial Carcinoma

By: JNCCN 360 Staff
Posted: Wednesday, September 1, 2021

On August 31, the U.S. Food and Drug Administration (FDA) granted full approval to the PD-1 inhibitor pembrolizumab (Keytruda) for the first-line treatment of patients locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy. Pembrolizumab was previously granted accelerated approval in this patient population whose tumors expressed PD-L1, as measured by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

The FDA approval was based on pembrolizumab’s effects on tumor response rate and duration of response. Continued approval for the indication is contingent on confirming pembrolizumab’s clinical benefit in future trials. In the phase III KEYNOTE-361 trial, patients with advanced or metastatic urothelial carcinoma who were eligible for platinum-containing chemotherapy were given pembrolizumab alone or in combination with chemotherapy. The study did not meet its primary endpoints of overall survival or progression-free survival, compared with standard-of-care chemotherapy.

In addition to this first-line indication, pembrolizumab is 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. Pembrolizumab is also approved for the treatment of patients with Bacillus Calmette-Guérin–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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