New Early Breast Cancer Drug NERLYNX, Now Approved in Malaysia

Singapore : A new breast cancer drug shown to significantly reduce the risk of cancer recurrence is now approved for use in Malaysia. The drug, NERLYNX (neratinib), is an oral medication taken by women with breast cancer who have had surgery, chemotherapy and prior trastuzumab-based therapy. It has been shown to significantly reduce the ongoing risk of recurrence in HER2+ early breast cancer patients,  with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy. For these women, the five-year risk of recurrence is reduced by up to 42%.

NERLYNX is approved in Malaysia for the extended adjuvant treatment of women with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago. It was also recently approved in Singapore by the HSA, an independent pharmaceutical company. Specialised Therapeutics Asia (STA) is making NERLYNX available in South East Asia under exclusive license from Puma Biotechnology Inc.


STA Chief Executive Officer Mr Carlo Montagner said the latest approval in Malaysia represented a key commercial milestone and highlighted the company’s expertise in navigating regulatory pathways in these complex regions. “Our regulatory team has worked tirelessly to secure these approvals for NERLYNX in Singapore and now Malaysia. NERLYNX is the first drug in our portfolio to be approved in these regions. We are now rapidly progressing other portfolio products through relevant regulatory channels to enable patients across South East Asia access to therapies where there is an unmet medical need. In the case of NERLYNX, we look forward to seeing women throughout South East Asia benefit from this important therapy, that provides an opportunity to improve outcomes for early breast cancer patients.”he commented.

Professor Arlene Chan was the lead investigator and primary author in the pivotal Phase 3 trial of NERLYNX, ExteNET. He stated that its availability in Malaysia, as well as Singapore, would be “a huge step forward” to further reduce the risk of cancer recurrence in local women diagnosed with HER2+ early breast cancer. “Despite the clear proven benefit of standard of care chemotherapy and trastuzumab therapy, women diagnosed with early-stage HER2+ breast cancer are still at risk of disease recurrence, this drug provides women with an opportunity to remain disease-free who may otherwise have had a recurrence.” added Professor Chan.

Data from the Malaysia National Cancer Registry Report (MNCRR) 2012-2016 demonstrates that the number of breast cancer cases being recorded in Malaysia is rising, with around 34 women in every 100,000 diagnosed with the disease between 2012 to 2016, compared to about 31 women between 2007 to 2011.

Singapore health data shows that breast cancer is the most common cancer in women in the country, accounting for almost 30% of all cancer cases. It is estimated that one in 15 women will be diagnosed with breast cancer before age 75.

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