26 June 2018 - Puma Biotechnology announced that the CHMP of the EMA has adopted a positive trend vote recommending the approval of the marketing authorisation application for neratinib for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer. 

Today’s decision follows a reexamination of the negative opinion announced by the CHMP at its formal meeting with the Company to discuss the application on February 23, 2018. 

The CHMP communicated its intention to hold a final vote at its next meeting.

Read Puma Biotechnology press release