- Puma Biotechnology (NYSE:PBYI) is up 2% after hours on the heels of its announcement that it plans to modify the summary product characteristics (product labeling) in its European marketing application for breast cancer candidate neratinib. Specifically, it will refine the intended treatment population to patients at high risk of disease recurrence.
- The change was based on feedback from the Committee for Medicinal Products for Human Use (CHMP) Scientific Advisory Group on Oncology. CHMP asked the group for an opinion on the clinical relevance of the five-year absolute treatment difference in invasive disease-free survival observed in the ExteNET study and on the risk of gastrointestinal toxicity with neratinib and its fit in the proposed patient population in the company's marketing application.
- CHMP will conduct an oral hearing on January 23 to discuss Puma's marketing application and has invited the company to present the risk/benefit profile of neratinib in the targeted population.
- Previously: EMA requests additional data analyses on Puma's marketing application for breast cancer med neratinib; extended timeline for approval pressures shares, down 4% after hours (Aug. 2, 2017)