By Merck & Co. has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to expand the approval of its popular cancer drug Keytruda. The recommendation specifically pertains to the use of Keytruda in combination with gemcitabine and cisplatin for the first-line treatment of adults with locally advanced unresectable or metastatic biliary tract carcinoma.
This recommendation was based on the findings of a phase 3 study, which demonstrated a statistically significant improvement in overall survival when Keytruda was used in combination with chemotherapy, as opposed to chemotherapy alone.
The European Commission, known to generally follow the advice of the CHMP, is expected to make a decision regarding expanded approval by the end of the year.
Merck is actively exploring the potential of Keytruda across a range of cancer types and treatment settings. This innovative drug, which leverages a patient’s immune system to combat tumors, has already been approved for numerous indications worldwide. In the first nine months of 2023 alone, Keytruda generated over $18 billion in sales.
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