FDA approves pembrolizumab for high-risk bladder cancer

FDA approved pembrolizumab (Keytruda—Merck & Co.) for the treatment of patients with unresponsive, high-risk, non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The drug is indicated for patients who are ineligible for or choose not to undergo the surgical removal of the bladder or cystectomy.

FDA approved pembrolizumab (Keytruda—Merck & Co.) for the treatment of patients with unresponsive, high-risk, non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The drug is indicated for patients who are ineligible for or choose not to undergo the surgical removal of the bladder or cystectomy. The approval was based on efficacy and safety results from KEYNOTE-057, a multicenter, single-arm trial that included 148 patients with high-risk NMIBC, including 96 who had bacillus Calmette-Guérin (BCG)-unresponsive CIS with or without papillary tumors. Patients in the trial received pembrolizumab 200 mg every 3 weeks for up to 24 months without disease progression. Among 96 relevant patients, the complete response rate was 41%, and the median response duration was 16.2 months, FDA said. In addition, 46% of responding patients underwent a complete response—defined as having negative results on cystoscopy, urine cytology, and CT urography imaging—lasting at least 12 months. The most common adverse events reported with pembrolizumab were fatigue, diarrhea, rash, pruritis, musculoskeletal pain, hematuria, cough, arthralgia, nausea, constipation, urinary tract infection, peripheral edema, hypothyroidism, and nasopharyngitis.