Merck Scores 2nd FDA Breakthrough Status For Keytruda

Merck announced that it has received a second Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Keytruda (pembrolizumab) — this time as a treatment for advanced non-small cell lung cancer (NSCLC).

Pembrolizumab is a humanized monoclonal antibody (mAb) that hinders the interaction between therapeutic target PD-1 and its ligands PD-L1 and PD-L2. The drug induces the release of the immune response’s PD-1 pathway-mediated inhibition, which includes anti-tumor immune response. The drug received Accelerated Approval under its first Breakthrough Therapy Designation from the FDA last month for the treatment of advanced or unresectable melanoma.

The new breakthrough designation was awarded to pembrolizumab as treatment for patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has further developed while undergoing or after completion of platinum-based chemotherapy. The designation was supported by findings from the ongoing Phase 1b KEYNOTE-001 study, which was presented at the European Society of Medical Oncology (ESMO) 2014 Congress last month.

“The anti-PD-1 antibody pembrolizumab has shown durable antitumor activity and acceptable toxicity in treatment-naïve and previously treated advanced NSCLC patients. Correlation between tumor PD-L1 expression and improved pembrolizumab antitumor activity has been observed,” ESMO reports.

Dr. Roger Perlmutter, president of Merck Research Laboratories, said, “The FDA’s Breakthrough Therapy Designation of KEYTRUDA underscores that new treatment approaches for advanced non-small cell lung cancer continue to be needed. Our data investigating the use of KEYTRUDA in this difficult-to-treat malignancy are very encouraging, and we look forward to working closely with the FDA to expedite our clinical program.” The designation helps lift prospects for 2015 in spite of the company recording a decrease of 4 percent in overall sales due to fewer vaccine sales, reports BioPharmaDive.

Merck has also filed a Marketing Authorization Application (MAA) for pembrolizumab in the EU as treatment for melanoma, which has been accepted for review by the European Medicines Agency (EMA).