Knight Therapeutics Announces Health Canada Approval For NERLYNX To Treat HER2-Positive Metastatic Breast Cancer

Author: Bill Haddad | July 06, 2021 08:07am

Knight Therapeutics Inc. (TSX:GUD), ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved NERLYNX® (neratinib) in combination with capecitabine for the treatment of adult patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting. The approval was based on results of the global Phase III NALA trial. Knight has the exclusive right to commercialize NERLYNX® in Canada under the terms of a license agreement entered into with Puma Biotechnology, Inc. (NASDAQ:PBYI).
 

According to Canadian Cancer Statistics, breast cancer accounts for one-quarter (25%) of all new cancer cases in women2. Approximately 27,700 women were diagnosed with breast cancer in 2020, and 5,100 died of the disease in the same year2. Studies show that up to 20% of breast cancer tumors 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 tumors 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 experience recurrence within 10 years, the majority of which are metastatic recurrences4-5.

"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."

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