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Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Malaysia for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner Specialised
About this update from Puma Biotechnology Inc
[{"type":"text","content":" LOS ANGELES--(BUSINESS WIRE)--\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX® (neratinib) in Malaysia from the Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH). NERLYNX is indicated 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.\n\n\nSTA Chief Executive Officer Carlo Montagner said, “This approval in Malaysia represents the fifth STA approval of NERLYNX for commercialization, after approvals in Australia, New Zealand, Singapore and Brunei. These approvals, along with pending regulatory submissions in the Philippines and other Southeast Asian regions, will extend the reach of this medicine to patients who were previously underserved.”\n\n\nAlan H. Auerbach, Chief Executive Officer and President of Puma, added, “The commercial strategy implemented by Specialized Therapeutics in Australia and the successful market entry into additional countries throughout Southeast Asia support our commitment to expanding access to NERLYNX to breast cancer patients around the world. Addressing recurrence in HER2-positive breast cancer patients remains paramount for Puma and our global partners.”\n\n\nAbout HER2-Positive Breast Cancer\n\n\nUp to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.\n\n\nAbout Puma Biotechnology\n\n\nPuma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib,...