Merck & Co., Inc. MRK announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion to the Marketing Authorization Application (“MAA”) for its blockbuster drug, Keytruda for expanded use. The MAA seeks label expansion of the drug as first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
A final decision from the European Commission on the MAA is expected in the first quarter of 2021.
Please note that the FDA had granted approval for a similar label expansion of the drug in June. Keytruda is already 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 in Europe. The approval of Keytruda provides a new monotherapy treatment option for this patient population.
The positive CHMP opinion 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.
Keytruda, Merck’s major revenue generating product, is already approved for use in more than 30 indications across several different tumor types in the United States.
Keytruda recorded sales of $10.4 billion in the first nine months of 2020, up 30% year over year. The drug’s sales were driven by the launch of new indications globally, particularly 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 1300 studies including 900 plus combination studies. Merck has collaborated with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.
