Puma Biotechnology (NASDAQ:PBYI) has submitted a supplemental marketing application to the FDA seeking approval to use Nerlynx (neratinib), combined with chemo agent capecitabine, to treat patients with HER2-positive metastatic breast cancer who have failed at least two prior lines of therapy.
The FDA approved the kinase inhibitor two years ago for the extended adjuvant treatment of early-stage HER2-positive breast cancer.
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