Puma Biotechnology announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive trend vote recommending the approval of neratinib for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer, five months after the regulator recommended against approving it.
The decision followed a reexamination of the negative opinion announced by the CHMP in February. The committee will hold a final vote at its next meeting.
Last year, U.S. Food and Drug Administration approved Puma’s drug, neratinib.
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