Merck & Co., Inc. (MRK - Free Report) announced that the FDA has accepted a supplemental biologics license application (sBLA) for its blockbuster PD-1 inhibitor, Keytruda. The supplementary application sought accelerated approval of Keytruda, as a monotherapy in adult and pediatric patients whose unresectable or metastatic solid tumors are tumor mutational burden-high (TMB-H) and who have progressed following prior treatment. With the FDA granting priority review to the sBLA, a decision is expected on Jun 16.
The sBLA was partly based on data from the phase II KEYNOTE-158 study. Please note that this is the second time Merck is looking for expanded approval of Keytruda based on a biomarker, regardless of cancer/ tumor type. In 2017, the FDA had approved Keytruda as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. That approval was also based in part on data from the KEYNOTE-158 study.
Merck’s shares have declined 13.6% this year so far, compared with the industry’s 7.9% decline.
Keytruda, Merck’s biggest product, is already approved for use in 23 indications across several different tumor types in the United States.
Keytruda recorded sales of $11 billion in 2019, up 58% year over ear. The drug’s sales were driven by the launch of new indications globally. Keytruda sales, particularly, are benefiting from strong momentum in the first-line lung cancer indication.
The Keytruda development program is also progressing well with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1200 studies including 600 plus combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens.
Undoubtedly, Keytruda’s solid growth prospects are based on increased utilization, approval for new indications and expectation of additional approvals worldwide.
Merck currently has 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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