Puma Biotech (NASDAQ:PBYI) received approval to market neratinib in Australia via its licensing partner, Specialised Therapeutics Asia, who has also submitted an application for regulatory approval in Singapore.
Neratinib, marketed as NERLYNX, is an extended adjuvant treatment for early stage HER2-overexpressed/amplified breast cancer. In Australia, the oral therapy was approved for use following adjuvant trastuzumab-based therapy, the same indication for which the FDA approved NERLYNX in July 2017. The EU granted marketing authorization for NERLYNX in hormone receptor-positive HER2-positive early stage breast cancer in September 2018.
Some 20% to 25% of breast cancers over-express the HER2 protein. Trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery. However, as many as 25% of patients treated with trastuzumab experience recurrence.
