By Colin Kellaher


Merck & Co. on Monday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its blockbuster cancer drug Keytruda for certain breast-cancer patients.

The Kenilworth, N.J., drugmaker said the recommendation covers Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, for adults with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.

Merck said the positive CHMP opinion is based on results from the a Phase 3 study in which the Keytruda regimen showed a significant event-free survival benefit.

The European Commission, which generally follows the CHMP's advice, is expected to make a decision during the second quarter, Merck said.

Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is approved in dozens of indications around the world. Sales of the drug topped $17 billion last year.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

04-25-22 0722ET