Merck (MRK) Announces FDA Accepts BLA with Priority Review and Grants Breakthrough Therapy Designation for KEYTRUDA for NSCLC

September 7, 2016 6:49 AM EDT

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Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Additionally, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication.

The submissions were based on data from the pivotal phase 3 KEYNOTE-024 study, which showed that KEYTRUDA monotherapy resulted in superior progression-free survival (PFS) as well as overall survival (OS) compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1 (tumor proportion score of 50 percent or more). Based on the results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive KEYTRUDA. Merck filed for approval of KEYTRUDA in the first-line setting at a dose of 200 mg every three weeks, the dose studied in KEYNOTE-024.

“Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with KEYTRUDA compared to chemotherapy is welcome news,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We appreciate the opportunity to work with regulatory authorities to make KEYTRUDA a first-line treatment option in non-small cell lung cancer.”

The FDA’s Breakthrough Therapy Designation is intended to expedite the availability of promising new therapies that are planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates substantial improvement over existing therapies on one or more clinically significant endpoints. Merck previously announced that KEYTRUDA (pembrolizumab) was granted breakthrough status for specific patients with advanced melanoma, metastatic NSCLC in previously treated patients, microsatellite instability high metastatic colorectal cancer, and relapsed or refractory classical Hodgkin Lymphoma.

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