Merck & Co., Inc. MRK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new label expansion of its blockbuster cancer drug, Keytruda in esophageal and gastroesophageal junction carcinoma.
The positive CHMP opinion is related to a marketing authorization application, seeking approval of the drug in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in patients whose tumors express PD-L1 (combined positive score ≥10). The European Commission will now review the CHMP’s recommendation and final decision on the label expansion is expected by the end of June.
Please note that a similar label expansion for Keytruda was approved by the FDA in March 2021.
The positive CHMP opinion and FDA approval was based on data from the phase III KEYNOTE-590 study, which evaluated Keytruda plus fluorouracil (“FU”) and cisplatin in the given patient population. Data from the same showed that treatment with the Keytruda combo led to significant improvement in overall survival, progression-free survival and objective response rate compared to FU and cisplatin alone, regardless of histology or PD-L1 expression status. The drug-chemotherapy regimen reduced the risk of death by 27% and reduced the risk of disease progression or death by 35%.
Shares of Merck have declined 3.4% so far this year against the industry’s increase of 7.4%.
We note that Keytruda is Merck’s major revenue-generating product. The drug recorded sales of almost $4 billion in the first quarter of 2021, up approximately 19% year over year.
Keytruda is continuously growing and expanding into new indications and markets, globally. In fact, the Keytruda development program is also progressing well as the drug is being studied for more than 30 types of cancer in more than 1450 studies, including several combination studies.
Merck has collaborated with several companies, including Amgen AMGN, Glaxo GSK and Pfizer PFE, separately, for the evaluation of Keytruda in combination with other regimens.
Zacks Rank
Merck currently 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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