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 a single-agent, extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified
Advisory Committee Vote
Is the risk/benefit profile of neratinib sufficient to support treatment in the proposed