Merck & Co., Inc. (MRK - Free Report) announced that a supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, Keytruda, has been accepted under priority review by the FDA.
With the latest application, Merck is looking to expand the label of Keytruda for the treatment of advanced cervical cancer with disease progression on or after chemotherapy. With the FDA granting priority review, a decision is expected on Jun 28.
This is the first time that the FDA has accepted a filing for an anti-PD-1 therapy in cervical cancer. Meanwhile, this is the fourteenth regulatory submission for Keytruda accepted by the FDA. The sBLA was based in part on data from phase II KEYNOTE-158 study.
This year so far, Merck’s shares have underperformed the industry. Merck’s shares have declined 1.6% in the period against 1.4% increase for the industry.
Keytruda is the second largest product in the Merck portfolio. It is marketed for many types of cancer and treatment settings including lung cancer, melanoma, head and neck cancer, classical Hodgkin’s lymphoma, gastric cancer, bladder cancer and microsatellite instability-high (MSI-H) or mismatch repair deficient cancer.
The treatment fetched sales of $3.8 billion in 2017, up almost 172% year over year. This upside is driven by the global launch of new indications, which further boosted demand. Keytruda sales are gaining, particularly from strong momentum in the first-line lung cancer indication. It is the only anti-PD-1 approved in the first-line setting both as a monotherapy as well as a combination therapy with Eli Lilly’s (LLY - Free Report) cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo).
The Keytruda development program also significantly advanced in 2017 with several regulatory approvals in the United States, Europe and Japan. The new approvals expanded the patient population, driving up sales last year. The positive momentum is expected to continue in 2018 as well.
Meanwhile, Keytruda is being studied for more than 30 types of cancer, in more than 700 studies, including in excess of 400 combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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