Puma Biotech (PBYI) to Modify Neratinib MAA Based on Feedback from CHMP's SAG - (StreetInsider via NewsPoints Desk)

  • Puma Biotech disclosed in a US Securities and Exchange Commission filing that an advisory group of the EU's Committee for Medicinal Products for Human Use was asked to provide an opinion on the clinical relevance of a finding in a Phase III trial of the company's breast cancer drug neratinib, reported StreetInsider.

  • Specifically, the group was asked for an opinion on the five-year absolute treatment difference in invasive disease-free survival seen in the ExteNET trial and on the risk of gastrointestinal toxicity with neratinib and its acceptability in the proposed patient population in Puma's European filing.

  • Based on feedback it receives, Puma said it intends to modify the European product label in its filing for neratinib "to further refine the intended population to patients at a high risk of disease recurrence."

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