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Pharmaceuticals / Submissions and Approvals

FDA Approves Merck’s Keytruda for First-Line NSCLC

May 18, 2017

The FDA granted accelerated approval to Merck’s Keytruda immunotherapy, as a first-line treatment for metastatic, nonsquamous non-small cell lung cancer in combination with chemotherapy, regardless of a patient’s PD-L1 expression.

The addition of Keytruda (pembrolizumab) to a regimen of carboplatin and pemextred nearly doubled the objective response rate in a clinical trial of 123 previously untreated patients — up to 55 percent, compared to 29 percent with chemotherapy alone. All responses were partial responses.

Patients who received the Keytruda combination therapy also showed a median PFS of 13.0 months, compared to 8.9 months with chemotherapy.

Keytruda is approved at a fixed dose of 200 mg administered as an intravenous infusion over 30 minutes every three weeks until disease progression, unacceptable toxicity, or up to 24 months.

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