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Monday, March 18, 2019

Puma Biotechnology partner STA receives marketing authorization in Australia

Puma Biotechnology announced that its licensing partner Specialised Therapeutics Asia, or STA, has received marketing authorization from Australia’s Therapeutic Goods Administration, or TGA, to commercialize NERLYNX in Australia for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab based therapy. STA has submitted regulatory applications to gain approval to introduce NERLYNX in Singapore. Further applications are planned by STA in other countries in South East Asia, including Malaysia, Brunei, Vietnam and Thailand.

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