Therapy Areas: Oncology
Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Singapore for Nerlynx for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive HER2-Positive Breast Cancer
5 December 2019 - - US-based biopharmaceutical company Puma biotechnology, Inc. (NASDAQ: PBYI) licensing partner, Specialised Therapeutics Asia, has received marketing approval of Nerlynx (neratinib) in Singapore from the Health Sciences Authority, a statutory board under the Ministry of Health of the Singapore government, the company said.

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.

Approximately 20 to 25% 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.

Puma 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 commercialisation rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.

Neratinib, oral was approved by the US Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as Nerlynx (neratinib) tablets.

Nerlynx was granted marketing authorization by the European Commission in August 2018 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 is a registered trademark of Puma biotechnology, Inc.
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