Puma Biotechnology asserted that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion thereby refuting to grant Marketing Authorization Application for neratinib for the extended adjuvant treatment of early stage HER-2 positive breast cancer.
Puma announced that the CHMP had communicated a negative trend vote after meeting with the Company to discuss the MAA and that a negative trend vote meant it was unlikely that CHMP would provide a positive opinion related to the Company’s MAA at the formal CHMP meeting.
CHMP’s vote was based on the results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.