NEW YORK – Canbridge Pharmaceuticals said on Thursday that it received approval from the Taiwan Food and Drug Administration to market neratinib (Puma Biotechnology's Nerlynx) as an extended adjuvant treatment for adult patients with early-stage, HER2-positive breast cancer after treatment with trastuzumab (Genentech's Herceptin).
Neratinib was approved in May by China's National Medical Products Administration and last November by the Department of Health in Hong Kong for the same indication.
In February, neratinib was also approved in the US in combination with the chemotherapy capecitabine for advanced or metastatic HER2-positive breast cancer patients who have received two or more anti-HER2 therapies.
Chinese company Canbridge acquired the exclusive rights to develop and commercialize neratinib in China, Taiwan, Hong Kong, and Macao in 2018. Under the agreement, Puma will receive an upfront payment of $30 million and potential milestone payments totaling up to $40 million. In addition, Puma will receive royalties on neratinib sales in greater China.
Recently, Puma Biotechnology announced that neratinib further demonstrated promising response rates in patients with HER2-mutant cervical cancer.