2020-02-26 08:13:45 PBYI Puma Biotechnology
02/26/20 02/2608:13 02/26/2008:13 | Puma Biotechnology announces FDA approval of neratinib with capecitabine sNDAPuma Biotechnology announced that the FDA approved a supplemental new drug application, or sNDA, for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens. | |
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