On January 23, 2018 Puma Biotechnology, Inc. (Nasdaq: PBYI) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a negative trend vote after meeting with the Company today to discuss the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer (Press release, Puma Biotechnology, JAN 23, 2018, View Source [SID1234523492]). 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 (iDFS) benefits observed to-date may lack sufficient clinical relevance.
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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.
About HER2-Positive Breast Cancer
Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.