Puma's Nerlynx Scores Broad Label Across Adjuvant Breast Cancer Subgroups

18 Jul 2017

• By Emily Hayes

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 Biotechnology Inc. scored a major victory with a broad approval of Nerlynx for early-stage HER2+ breast cancer by the US FDA, even though the disease-free survival benefit in the pivotal ExteNET study was driven by particular subgroups of women.

FDA approved Nerlynx (neratinib), which is a tyrosine kinase inhibitor, on July 17 for extended adjuvant treatment of adult patients...