- Health Canada has approved NERLYNX® (neratinib) for the treatment of metastatic HER2-overexpressed/amplified breast cancer
- NERLYNX® is a potent irreversible tyrosine kinase inhibitor
- 20% of breast cancer tumours have an over-expression of the HER2 protein
- NERLYNX® is now covered by several private insurance companies in Canada
- Knight Therapeutics Inc is a specialty and generic drug manufacturing company
- Knight Therapeutics Inc. (GUD) opened trading at C$5.25 per share
Health Canada has approved NERLYNX® (neratinib) for the treatment of metastatic HER2-overexpressed/amplified breast cancer.
Knight has the exclusive right to commercialize NERLYNX® in Canada under the terms of a license agreement entered into with Puma Biotechnology, Inc.
According to Canadian Cancer Statistics, breast cancer accounts for one-quarter of all new cancer cases in women. Approximately 27,700 women were diagnosed with breast cancer in 2020, and 5,100 died of the disease in the same year.
Studies show that up to 20% of breast cancer tumours have an over-expression of the HER2 protein. Women with breast cancer that over-expresses HER2 referred to as HER2-positive breast cancer, are at greater risk for disease progression and death than women whose tumours do not over-express HER2.
Although research has shown that trastuzumab can reduce the risk of early-stage HER2-positive breast cancer recurring, up to 25% of treated patients experienced recurrence within 10 years, the majority of which are metastatic recurrences.
“We are pleased to provide Canadian HER2-positive breast cancer patients and physicians with an effective medicine following previous treatment with other anti-HER2 agents in the metastatic setting,” said Jody Engel, Country Manager Canada at Knight Therapeutics Inc.
“This approval will add another indication to NERLYNX’s current usage in extended adjuvant breast cancer.”
NERLYNX® is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the human epidermal growth factor receptors, HER1, HER2 and HER4. On July 16, 2019, Health Canada approved NERLYNX® for the extended adjuvant treatment of women with early-stage hormone receptor-positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.
NERLYNX® is now covered by several private insurance companies in Canada.
Knight Therapeutics Inc. is a Canadian-based pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for Canada and Latin America.
Knight Therapeutics Inc. (GUD) opened trading at C$5.25 per share.