CHMP recommends change of approval of Keytruda in triple negative breast cancer.- MSD
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Keytruda (pembrolizumab) from Merck Sharp & Dohme for triple negative breast cancer.
The CHMP adopted a new indication as follows: Keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence.
Learning Zones
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