NERLYNX (neratinib) treatment of HER2-positive metastasis breast cancer: will be approved in Canada.

Up to 20% of breast cancer patients have expressed HER2 protein.
HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progress and death.
according to the Canadian Population Study, about 6.6 to 8 percent of HER2-positive breast cancers are metastasis, with an average total survival of about 28.1 months for metastasis HER2-positive breast cancer patients.
pharmaceutical company Knight announced today that it has filed a supplementary document (SNDS) in Canada for the declaration of a new drug for THELYNX (neratinib) to treat HER2-positive metastasis breast cancer.
SNDS is supported by the results of the Phase III NALA trial, which evaluated the effectiveness and safety of NERLYNX (neratinib) combined with Capatham vs. Tykerb® (Lapatini) combined with Capatinib to treat HER2-positive metastasis breast cancer patients.
621 patients for the trial, which was conducted in North America, Europe, Asia Pacific and South America.
the main endpoints of the trial were progress-free lifetime (PFS) and overall lifetime (OS).
results showed that NERLYNX (neratinib) combined carpattabon therapy significantly improved PFS (risk ratio 0.76, 95% CI 0.63-0.93, p . . . 0.0059) compared to Rapatini's combined carpattabin.
Samira Sakhia, President and Chief Operating Officer of
Knight Therapeutics, said, "We are pleased to present NERLYNX's new adaptation to Health Canada, enabling us to offer new treatment options to Canadian patients."
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