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Puma Biotechnology's Nerlynx Receives Marketing Approval in Malaysia

NEW YORK – Puma Biotechnology said on Thursday that its licensing partner Specialized Therapeutics Asia (STA) has received marketing approval for neratinib (Nerlynx) from the Drug Control Agency of Malaysia's Ministry of Health.

Puma and STA entered an exclusive licensing agreement in 2017 to commercialize neratinib in Australia, New Zealand, and Southeast Asia.

Neratinib will now be available in Malaysia as an extended adjuvant treatment for patients with hormone receptor-positive, HER2-overexpressing or HER2-amplified early-stage breast cancer who have completed adjuvant therapy with trastuzumab (Genentech's Herceptin) less than a year ago.

"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 [neratinib] to breast cancer patients around the world," Puma CEO Alan Auerbach said in a statement. "Addressing recurrence in HER2-positive breast cancer patients remains paramount for Puma and our global partners."

The US Food and Drug Administration recently expanded the approval for neratinib to advanced or metastatic HER2-positive breast cancer patients who have received two or more prior anti-HER2 therapies. 

It was also approved in China this year as an extended adjuvant treatment of patients with early-stage, HER2-positive breast cancer after treatment with trastuzumab. 

Puma Biotechnology is pursuing various licensing partnerships to help commercialize neratinib globally. In May, it announced an agreement with Bixink Therapeutics to commercialize the drug in South Korea.