Merck's Lung Cancer Drug Keytruda Under Priority Review

Merck & Co., Inc.’s (NYSE:MRK) supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, Keytruda has been accepted for priority review by the FDA.

The company is looking to expand the label into the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1.

With the FDA granting priority review, a response should be out by Dec 24, 2016. Additionally, the FDA granted Breakthrough Therapy designation to the drug for this indication. The sNDA submissions were based on positive data from pivotal phase 3 KEYNOTE-024 study, which showed that Keytruda led to significant improvement in survival in patients with high PD-L1 expression compared to chemotherapy. The drug is also under review in the EU for this indication.

Keytruda is currently approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. It is also approved for the treatment of metastatic NSCLC patients whose tumors express PD-L1 as determined by an FDA-approved test and whose disease has progressed on or after platinum-containing chemotherapy. It is also approved for the first-line treatment of patients with unresectable or metastatic melanoma advanced melanoma in patients refractory to Yervoy.

Keytruda is being studied for more than 30 forms of cancers including melanoma, NSCLC, head and neck, bladder, gastric, colorectal, esophageal, breast, ovarian, Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, nasopharyngeal, and others. Merck is collaborating with several companies including Amgen, Inc. (NASDAQ:AMGN) , Incyte, GlaxoSmithKline plc (NYSE:GSK) and Pfizer Inc. (NYSE:PFE) among others separately for the evaluation of Keytruda in combination with other regimens.

Keytruda also has Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL), specific patients with advanced melanoma, advanced non-small cell lung cancer (NSCLC), and advanced colorectal cancer.

Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Confidential from Zacks

Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>