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Merck Lung Cancer Drug Acquires FDA Breakthrough Designation, Priority Review

September 14, 2016

FDA has granted Priority Review and a Breakthrough Therapy Designation to Merck’s Keytruda immunotherapy for first-line treatment in patients with non-small cell lung cancer whose tumors express PD-L1. The agency has set a target date of Dec. 24 for final approval.

Keytruda (pembrolizumab) previously received accelerated approval from FDA to treat NSCLC that has progressed after other treatments and expresses PD-L1 as determined by a companion diagnostic test. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency.

Merck based its BLA on data from the Phase III study, which showed that Keytruda monotherapy improved progression-free survival and overall survival compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1.

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