Puma Biotech (NASDAQ:PBYI) received approval to market neratinib in China via its licensing partner, CANbridge Pharmaceuticals.
Neratinib, marketed as NERLYNX, is an extended adjuvant treatment for early stage HER2-overexpressed/amplified breast cancer. The oral therapy was approved for use following adjuvant trastuzumab-based therapy, the same indication for which the FDA and Australia’s Therapeutic Goods Administration approved NERLYNX in July 2017 and March 2019, respectively.
“Reducing the risk of recurrence in HER2-positive early stage breast cancer patients remains paramount for Puma and our global partners,” Alan Auerback, Puma’s president and CEO, said in a statement.
“Marketing approval in the region represents an important milestone as we continue to execute on our global commercial strategy,” he added.
