Merck & Co., Inc.’s MRK yet another supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, Keytruda, has been accepted for priority review by the FDA.
This time, the company is looking to expand the label for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer i.e. patients whose tumors harbor DNA repair defects.
With the FDA granting priority review, a response should be out by Mar 8, 2017. Previously, the FDA granted Breakthrough Therapy designation to the drug for both unresectable and metastatic MSI-H non-colorectal and colorectal cancers. The sNDA submission was based on positive data from five phase I/II trials that studied Keytruda in MSI-H cancer. The sBLA, which is seeking approval of a fixed dose of 200 mg of Keytruda every three weeks, will be reviewed under the FDA’s Accelerated Approval program.
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 first-line treatment of patients with unresectable or metastatic melanoma in patients refractory to Yervoy.
It is also approved for the treatment of metastatic lung cancer (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. In October, Keytruda received an earlier-than-expected FDA approval for the first-line treatment of metastatic lung cancer. This is an important milestone for the company and Keytruda sales should improve sharply with the first-line NSCLC indication. Additionally, in August, Keytruda was approved for previously treated recurrent or metastatic head and neck cancer (HNSCC).
New products like Keytruda have been contributing meaningfully to Merck’s top line, somewhat making up for the generic competition for several drugs. Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied for more than 30 types of cancer. Merck is collaborating with several companies including Amgen, Inc. AMGN, Incyte, GlaxoSmithKline plc GSK and Pfizer Inc. PFE among others separately for the evaluation of Keytruda in combination with other regimens. The last few months have seen a series of positive news regarding Keytruda, raising sales expectations for the drug. Further, label expansion of the key drug should significantly boost sales of Merck.
Merck currently carries a Zacks Rank #3 (Hold).
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