Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Singapore for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive HER2-Positive Breast Cancer

On December 2, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX (neratinib) in Singapore from the Health Sciences Authority (HSA), a statutory board under the Ministry of Health of the Singapore Government (Press release, Puma Biotechnology, DEC 2, 2019, View Source [SID1234551817]). NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

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STA Chief Executive Officer Carlo Montagner said, "The approval in Singapore is a key milestone for the company as NERLYNX is the first drug in our portfolio to be approved by the HSA for commercialization in Singapore. We look forward to extending the reach of this medicine, with regulatory dossiers also submitted in Malaysia, Brunei and the Philippines."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "We have been extremely pleased with the strong commercial strategy implemented by Specialised Therapeutics in Australia and we look forward to their continued success throughout South East Asia. We are committed to expanding access to NERLYNX to breast cancer patients around the world."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. 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 returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.