Neratinib’s FDA Panel Nod Weighed Down By Indication Breadth Worries

25 May 2017

Puma’s tyrosine kinase inhibitor gains recommendation from US advisory committee but faces concerns that proposed indication for extended adjuvant treatment in HER2-positve breast cancer is overly broad given unfavorable subgroup results in pivotal trial.

Puma Biotechnology Inc.’s tyrosine kinase inhibitor Nerlynx (neratinib) appears headed for approval following a positive US FDA advisory committee recommendation May 24, although the breadth of the label for the adjuvant breast cancer drug remains in question.

An overwhelming majority of Oncologic Drugs Advisory Committee members concluded that neratinib’s risk/benefit profile is sufficient to support use as...