Puma Biotechnology says CHMP to discuss neratinib on January 23
Puma Biotechnology announced last night that it met with Europe's Committee for Medicinal Products for Human Use Scientific Advisory Group on Oncology. SAG was asked to provide an opinion on the clinical relevance of the five-year absolute treatment difference in invasive disease free survival seen in the Phase III ExteNET trial and on the risk of gastrointestinal toxicity with neratinib and its acceptability in the proposed patient population in the company's Marketing Authorization Application for neratinib, Puma said. Based on the feedback from SAG and the rapporteurs, the company intends to modify the summary of product characteristics, sometimes referred to as the European product label, in its MAA for neratinib to further refine the intended population to patients at a high risk of disease recurrence. Puma noted that CHMP will be conducting an oral hearing to discuss the MAA for neratinib on January 23, and that it has been invited to present the risk benefit profile of neratinib in the identified population at this meeting.