Neratinib’s FDA Panel Nod Weighed Down By Indication Breadth Worries
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.
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US FDA labeling details the differences in performance of neratinib in adjuvant breast cancer by subgroup, as well as results relative to the timing of Roche's Herceptin, but the drug's indication covers all.
Puma is in select company after winning a strong vote from US FDA’s Oncologic Drugs Advisory Committee in favor of approval of its new cancer drug neratinib.