Puma Biotechnology met SAG to provide an opinion on the clinical relevance of the 5-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.

On January 11, 2018 Puma Biotechnology, Inc. (the "Company") reported it met today with the Committee for Medicinal Products for Human Use ("CHMP") Scientific Advisory Group on Oncology ("SAG") (Press release, Puma Biotechnology, JAN 11, 2018, View Source [SID1234523065]). SAG was asked to provide an opinion on the clinical relevance of the 5-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 ("MAA") for neratinib. Based on the feedback from SAG and the rapporteurs, the Company intends to modify the summary of product characteristics ("SmPC"), 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.

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CHMP will be conducting an oral hearing to discuss the MAA for neratinib on January 23, 2018, and the Company has been invited to present the risk benefit profile of neratinib in the identified population at this meeting