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Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration
About this update from Puma Biotechnology Inc
[{"type":"text","content":" LOS ANGELES--(BUSINESS WIRE)--\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (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.\n\n\n“Although there have been many new treatment options for patients with HER2-positive breast cancer, patients still need additional treatment options once they progress,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “Based on the results of our NALA data, we believe NERLYNX® could be a promising therapeutic opportunity for these patients.”\n\n\nAdam M. Brufsky, MD, Ph.D., of Magee-Womens Hospital and the Hillman Cancer Center at the University of Pittsburgh Medical Center, added, “Together with the NALA investigators around the world, I am pleased to see the FDA approval of NERLYNX for the treatment of advanced HER2-positive metastatic breast cancer. This approval is based on data from the NALA trial, which we presented at ASCO last year, demonstrating that neratinib in combination with capecitabine offers a significant improvement over currently available therapies in this heavily pretreated patient population and can be added to NERLYNX’s established role in the treatment of early breast cancer.”\n\n\nIn the United States, NERLYNX is approved for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy. In Europe, NERLYNX is approved for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX has also received approval for use in the extended adjuvant setting in Canada, Australia, Hong Kong, Singapore and Argentina.\n\n\nIn collaboration with its global licensing p...