EMA/CHMP recommendations on drug indication extensions
As well as several novel medicines approvals decisions announced on Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) also recommended several extensions of indications for already marketed drug. A final decision regarding the approvals is expected from the European Commission in the near future.
Added uses for Keytruda
Among these, the CHMP has adopted a positive opinion recommending approval of Keytruda (pembrolizumab), Merck & Co’s (NYSE: MRK) blockbuster anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab (the Keytruda regimen), for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).
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