Merck Gets Positive CHMP Opinion for Updated Keytruda Label

March 31, 2021

The European Medicines Agency’s human medicines committee (CHMP) has issued a positive opinion for Merck’s blockbuster cancer drug Keytruda (pembrolizumab), which would allow the company to update its bladder cancer label to include new phase 3 study findings.

While Keytruda did not meet its endpoints of progression-free and overall survival, CHMP said the drug’s benefits and risks remained positive and that including the data on the label would help doctors evaluate the drug when deciding if they should use it.

Keytruda, which is approved for treatment of multiple cancers, increased worldwide sales by 30 percent to $14.4 billion in 2020.

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