Puma Applies to FDA to Extend Nerlynx’s Use to HER2-Positive Metastatic Breast Cancer

Puma Applies to FDA to Extend Nerlynx’s Use to HER2-Positive Metastatic Breast Cancer
Puma Biotechnology is seeking to extend the use of its breast cancer medicine Nerlynx (neratinib), in combination with capecitabine, to treat women with HER2-positive breast cancer whose disease has spread to other parts of the body, and is metastatic. In a supplemental New Drug Application (sNDA) filed with the U.S. Food and Drug Administration (FDA), Puma seeks the use of the Nerlynx-capecitabine combo for women who have failed two or more prior lines of targeted therapy. The application is based on results from the NALA Phase 3 trial, which found that Nerlynx prolonged patients' lives without disease worsening as compared with Novartis' Tykerb (lapatinib), another therapy for HER2-positive breast cancer. "We are very pleased to announce this important regulatory milestone,” Alan H. Auerbach, CEO and president of Puma, said in a press release. “Although the use of HER2 directed agents in the metastatic setting has positively impacted the treatment of the disease in the first and second line settings, patients with HER2 positive metastatic breast cancer who have progr
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