Phase III


Neratinib is the first anti-HER2 treatment FDA-approved as extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. Treatment with neratinib resulted in a 34% reduction in the risk of invasive disease recurrence or death versus placebo after patients completed one year of therapy following a trastuzumab-based regimen. Neratinib addresses an unmet medical need, as up to 25% of HER2-positive early-stage breast cancer patients treated with trastuzumab-based adjuvant treatment experience a recurrence.

CANbridge has licensed the exclusive rights to develop and commercialize NERLYNX (neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China) from Puma Biotechnology, Inc. (Nasdaq: PBYI).

Indication: HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

NERLYNX® is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. The recommended dose for neratinib is 240 mg (40 mg × 6 tablets) taken orally, once daily with food, continuously for one year.