Specialised Therapeutics Asia to make NERLYNX (neratinib) available to women in Singapore.
A new breast cancer drug shown to significantly reduce the risk of cancer recurrence is now available to women in Singapore via a special access program.
The drug, NERLYNX (neratinib) is an oral medication taken by women with HER2+ early breast cancer who have completed adjuvant trastuzumab-based therapy. Neratinib is an irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.
Five-year follow up data showed the drug reduced risk of invasive disease recurrence or death by 42 percent in women with early stage HER2+/HR+ (hormone-receptor positive) breast cancer.
In these patients, invasive disease-free survival (iDFS) was 90.8 percent in the patients treated with neratinib, compared with 85.7 percent in those receiving placebo.
NERLYNX is made available in Singapore by Specialised Therapeutics Asia, under exclusive license from Puma Biotechnology. The drug is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and was not expected to be approved by the Singapore Health Sciences Authority (HSA) before 2020.
Breast cancer is the most common cancer in women in Singapore, accounting for almost 30 percent of all cancer cases. Therefore, it is critical that women in Singapore who have recently completed adjuvant trastuzumab-based therapy or are about to complete adjuvant trastuzumab-based therapy, are provided access to NERLYNX now, as the greatest benefit is seen in women who commence therapy as soon as possible. [APBN]