Urothelial Carcinoma Drug Receives FDA Approval

The FDA has approved Keytruda (pebrolizumab) 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, and granted accelerated approval for the treatment of patients who are not eligible for cisplatin-containing chemotherapy.

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The regular approval was based on the results of a multicenter, randomized, active-controlled trial of patients assigned to receive either pembrolizumab 200 mg every 3 weeks (n=270) or one of several chemotherapy options (n=272). Those treated with pembrolizumab experience statistically significant improvements in overall survival and objective response rate compared with chemotherapy.

The accelerated approval was based on the results of a single-arm, open-label trial in 370 participants. After a median follow-up of 7.8 months, the objective response rate was 28.6% and the median response duration was no reached.

The most common adverse reactions were fatigue, musculoskeletal pain, pruritus, decreased appetite, nausea, diarrhea, constipation, and rash.

—Michael Potts

Reference:

Pebrolizumab (Keytruda): advanced or metastatic urothelial carcinoma [press release]. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm. May 18, 2017.