FDA approves two indications for Keytruda (pembrolizumab) to treatlocally advanced or metastatic urothelial carcinoma.- Merck Inc.

Merck Inc. has announced that the FDA has approved two new indications for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

In the first-line setting, Keytruda is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

In the second-line setting, Keytruda is now 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. Keytruda is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Comment:In addition to Tecentriq (atezolizumab) from Genetech/Roche, Opdivo (nivolumab) from BMS, Bavencio (avelumab) from Pfizer + Merck KgAA and Imfinzi (durvalumab) from AstraZeneca are all approved for second-line bladder cancer and all based on mid-stage data. Merck had announced in February 2017 that the FDA accepted filings for Keytruda in first-line and second-line advanced bladder cancer. Unlike its competitors, Merck has positive overall survival data from the Keynote-045 study to support a Keytruda indication in bladder cancer and its abstract for ASCO showed Keytruda had extended overall survival by 10.3 months compared with 7.4 months for chemotherapy.