Puma Biotechnology asserted that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has conveyed a negative trend vote after discussions for the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.
Negative trend vote implies that CHMP is unlikely to assent to MMA at the formal CHMP decision vote slated for February 2018. CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival (iDFS) benefits observed to-date may lack sufficient clinical relevance.
An estimate suggests that 20-25% of breast Cancer tumors over- exhibit the HER2 protein. HER2-positive breast cancer is meant to pose more aggressiveness as compared to other types of breast cancer thereby increasing the risk of disease progression and death. Research however suggests otherwise that trastuzumab can reduce the risk of early stage HER2-positive breast cancer occurring after surgery, up to 25% of patients however display recurrence post treatment.