Puma Biotechnology Announces Meeting of Scientific Advisory Group on Oncology in Europe to Review Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

On December 13, 2017 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that the European Medicines Agency (EMA) has requested that the Scientific Advisory Group on Oncology provide an opinion on the clinical aspects of the Marketing Authorization Application (MAA) for neratinib at a meeting to be held on January 11, 2018 (Press release, Puma Biotechnology, DEC 13, 2017, View Source [SID1234522635]). In Europe, neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab containing regimen.

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The Scientific Advisory Group on Oncology is convened at the request of the EMA to provide independent recommendations on scientific or technical matters related to pediatric and adult clinical oncology and hematology, or on any other scientific issue relevant to the work of the EMA that relates to this area.

Puma Biotechnology announced on August 22, 2016 that the MAA for neratinib had been validated by the EMA. The MAA for neratinib is based on 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 August 2, 2017, Puma announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, had issued its Day-180 List of Outstanding Issues in the process of their ongoing regulatory review of Puma’s MAA. The Company expects to respond to the Day-180 List of Outstanding Issues by the deadline of December 22, 2017.