Puma says EMA communicates negative trend vote over MAA for neratinib
Puma Biotechnology (PBYI) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has communicated a negative trend vote after meeting with the company today to discuss the Marketing Authorisation Application for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.
A negative trend vote means it is unlikely that CHMP will provide a positive opinion related to the Company’s MAA at the formal CHMP decision vote scheduled in February 2018, and that additional steps would need to be taken to gain marketing approval in Europe.
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 benefits observed to-date may lack sufficient clinical relevance.
CHMP’s opinion 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.
On July 17, 2017, the company announced that the U.S. FDA has approved #NERLYNX (neratinib), formerly known as #PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. The drug became commercially available in September of 2017 under the trade name as NERLYNX.
Last September, Puma Biotechnology (PBYI) presented positive results from the Phase III clinical trial of Puma’s drug neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy in a proffered paper oral session at the European Society of Medical Oncology 2017 Congress in Madrid, Spain.
Today’s EMA decision was a surprise to the market. PBYI closed at $90.90. Shares last traded at $66.00 in extended trading.
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