The oral medication is available in Singapore via Special Access Program.

A new breast cancer drug shown to significantly reduce the risk of cancer recurrence is being made available to women in Singapore via a subsidised Special Access Program. This program provides patients with access to life-saving therapies where there is an unmet medical need, such as in situations where the treatment option is absent and the patient’s health will be clinically compromised without treatment with the unregistered therapeutic product.

The new drug Nerlynx (neratinib) is an oral medication taken by women with HER2+ breast cancer who have completed adjuvant trastuzumab-based therapy. It works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply. It has been shown to significantly reduce the ongoing risk of recurrence in HER2+ early breast cancer patients.

The greatest benefit was observed in women who were also hormone-receptor positive (HR+) and treated within 12 months following completion of trastuzumab-based adjuvant therapy. Their five-year risk of recurrence or death was reduced by 42 percent. 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 a placebo. Nerlynx is made available in Singapore by Specialised Therapeutics (ST) Asia, under exclusive license from Puma Biotechnology.

ST Asia CEO Carlo Montagner said a formal registration decision was not expected by Singapore’s Health Sciences Authority (HSA) before 2020, although he noted that Nerlynx is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

“Data from the pivotal clinical trial tells us that the greatest benefit is seen in women who commence therapy as soon as possible after their adjuvant trastuzumab-based treatment has been completed,” he said. “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 now to Nerlynx while the registration process is underway.”

International breast cancer authority Professor Arlene Chan was the lead investigator and primary author in the pivotal Phase III trial of Nerlynx, ExteNET. She said its availability in Singapore and other regions would be “a huge step forward” to further reduce the risk of cancer recurrence in local women diagnosed with HER2+ early breast cancer.

Approximately 15 to 20 percent of breast cancer tumours over-express the HER2 protein. HER2+ breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early-stage HER2+ breast cancer returning after surgery, over 25 percent of patients treated with trastuzumab experience recurrence.

“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,” Professor Chan said. “This drug provides women with an opportunity to remain disease-free who may otherwise have had a recurrence.”

Those in the Special Access Program, which is only available through the Nerlynx Access Program Singapore, will receive the drug at a discounted cost under the co-payment schedules, explained ST. The company further added that common side effects of Nerlynx can include diarrhoea, liver problems, stomach pain, feeling or being sick, low appetite, dry or inflamed mouth, including blisters or mouth ulcers, rash, muscle spasms or cramps, and feeling very tired.

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

 

---