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...
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