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Pharmaceuticals / Submissions and Approvals

FDA Expands Keytruda Approvals in First- and Second-Line Bladder Cancer

May 23, 2017

The FDA approved two new indications for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma.

In the first-line setting, Keytruda was granted accelerated approval for patients ineligible for cisplatin-containing chemotherapy. In the second-line setting, Keytruda is now approved for patients with disease progression following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Keytruda was approved for both indications at a fixed dose of 200 mg every three weeks until progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Keytruda’s clinical development program includes more than 30 tumor types in nearly 500 clinical trials, including more than 250 trials that combine Keytruda with other cancer treatments, according to Merck.

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