Puma Biotech breast cancer drug likely approved in Europe after reexamination

A committee of the European Medicines Agency is likely to approve the drug, five months after regulators recommended against approval

June 26, 2018

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.

Read the full release here