Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted approval to its blockbuster PD-1 inhibitor, Keytruda for the first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Keytruda is presently approved to treat MSI-H or dMMR colorectal cancer in patients whose cancer has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Until now, for treating first-line unresectable or metastatic MSI-H colorectal cancer, chemotherapy containing regimens were the only treatment options available. The approval of Keytruda provides a new monotherapy treatment option for this patient population.
The approval came less than a month following filing of the supplemental biologics license application (sBLA). The sBLA was based on data from the phase III KEYNOTE-177 study, which showed that Keytruda significantly reduced the risk of disease progression or death by 40%, compared to the current standard-of-care chemotherapy regimen in the above patient population. In the study, the median progression-free survival was 16.5 months, more than double of 8.2 months for chemotherapy. The sBLA was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program.
Merck’s shares have lost 16.3% this year so far compared with the industry’s 4.1% decline.
Keytruda, Merck’s biggest product, is already approved for use in more than 20 indications across several different tumor types in the United States.
Keytruda recorded sales of $3.3 billion in the first quarter of 2020, up 45% year over year. 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 850 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.
Merck currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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