New breast cancer therapy to reduce risk of cancer recurrence receives approval in Thailand

February 12, 2025 | Wednesday | News

Obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer

A new breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand.

NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc.

NERLYNX (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (FDA) as a single agent for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago. 

Additionally, NERLYNX has been approved in combination with capecitabinefor 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.

NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), ChinaLatin AmericaAustraliaCanada, and Hong Kong.

Coinciding with the NERLYNX approval, ST has announced the growth of its Thailand office, with new field force members due to join the company in March 2025.

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