New Breast Cancer Therapy to Reduce Risk of Recurrence and Improve Disease-Free Survival Now Available in Thailand

Eligible women with breast cancer in Thailand now have access to a new therapy, NERLYNX^® (neratinib), for the first time
The launch of NERLYNX provides an important new treatment option for women diagnosed with human epidermal growth factor receptor 2 positive (HER2+) breast cancer
This follows the approval of NERLYNX by the Thai FDA in December 2024 as a single agent for the treatment of early-stage HER2+ breast cancer, and in combination with capecitabine for the treatment of advanced or metastatic HER2+ breast cancer¹

SINGAPORE, Jan. 22, 2026 /PRNewswire/ — A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now available in Thailand.^1-3

Delivered as an oral tablet, NERLYNX^® (neratinib) was approved for use by the Thai FDA in December 2024:

As a single agent “for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.”¹; and
In combination with capecitabine “for the treatment of adult patients with advanced or metastatic HER2+ breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.”¹

Approximately 15-25% of all breast cancer tumours are positive for human epidermal growth factor receptor 2 (HER2+), which is associated with an increased risk of metastasis and disease recurrence, and decreased overall survival.^4,5 An estimated 26% of HER2+ breast cancer patients experience disease recurrence following treatment with trastuzumab.³

ST Medical Lead for Southeast Asia, Dr Bhuvana Ramaswamy, said the availability of NERLYNX would be welcome news for Thai oncologists and people with early or metastatic HER2+ breast cancer, who will now have access to this new treatment option for the first time.

“Breast cancer remains the most prevalent cancer among Thai women, with over 20,000 new cases diagnosed annually, and more than 4,800 deaths occurring each year,” said Dr Ramaswamy.

“In patients with early or metastatic HER2+ breast cancer, the risk of disease progression and recurrence is a significant concern, despite prior treatment with anti-HER2 therapies. The availability of NERLYNX in Thailand provides these patients with an important new treatment option that may reduce the possibility of experiencing a relapse, while also helping to improve progression free survival,” said Dr Ramaswamy.

In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in HER2+ women, 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.^2,3 For these women, the five-year risk of recurrence is reduced by up to 42%.⁶

In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression-free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).⁷ The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.^7,8

NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc. (Nasdaq: PBYI).

ST Chief Executive Officer, Mr Carlo Montagner, said NERLYNX is the first therapy the company is launching in Thailand and is in response to the need from local oncologists for new treatment options that can reduce cancer recurrence and relapse in women with HER2+ breast cancer.

“We are thrilled to be able to make this therapy available to eligible patients with HER2+ breast cancer in Thailand for the first time, providing a treatment option that can protect against progression or recurrence in either the early or advanced stages of their disease,” he said.

“Following the approval of NERLYNX by the Thai FDA late last year, we established a dedicated local field team to connect with Thai oncologists around the country, demonstrating our commitment to improving outcomes for breast cancer patients, as well as supporting the broader clinical and patient cancer community in Thailand,” said Mr Montagner.

Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.⁹ The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).^10,11 In 2022, breast cancer accounted for almost a quarter (23.2%) of all new cancer diagnoses in Thai women with 21,628 cases diagnosed that year.⁹

Ends.

About NERLYNX

NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.¹² It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.^13,14

NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2+ breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong.

About HER2+ Breast Cancer

Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2+ breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.^12,15,16

While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.¹⁶

About the ExteNET Study^2,3,6,17

The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2+ breast cancer.

The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2+ breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation.

The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The five-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab.

The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

About the NALA Study^7,8

The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia.

The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086).

The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

About Specialised Therapeutics

Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas.

Additional information can be found at www.stbiopharma.com.

References:

1. Thailand Food and Drug Administration. Public Pharmaceutical Regulatory Information: NERLYNX. Available at: https://pertento.fda.moph.go.th/FDA_INFORMATION_DRUG/Home/Phar_Product_Inform_Page?Newcode=U1DR1C1012671509711C [Accessed Dec 2025].

2. Martin M, et al. Lancet Oncol 2017;18(12):1688-1700.

3. Chan A, et al. Lancet Oncol 2016 Mar;17(3):367-377.

4. Hou Y, Nitta H, Li Z. HER2 Intratumoral Heterogeneity in Breast Cancer, an Evolving Concept. Cancers. 2023;15(10):2664.

5. Orrantia-Borunda E, et al. Subtypes of Breast Cancer. In: Mayrovitz HN, editor. Breast Cancer [Internet]. Brisbane (AU): Exon Publications; 2022 Aug 6. Chapter 3. Available from: https://www.ncbi.nlm.nih.gov/books/NBK583808.

6. Gnant, M et al. Poster: Presented at the 41st Annual San Antonio Breast Cancer Symposium (SABCS), 4-8 December 2018, San Antonio, Texas.

7. Saura C, et al. J Clin Oncol 2020;38(27):3138-3149.

8. Saura C, et al. J Clin Oncol 2019;37 (suppl; abstr.1002).

9. World Health Organization. GLOBOCAN 2022: Thailand Factsheet. Available at: https://gco.iarc.who.int/‌media/‌globocan/factsheets/populations/764-thailand-fact-sheet.pdf [Accessed Dec 2025].

10. Ditsatham C, et al. BMC Cancer 2022;22:1147.

11. Lakha F, et al. HPP 2020;35(9):1159–1167.

12. Tiwari SR, Mishra P, Abraham J. Clin Breast Cancer 2016;16(5):344-348.

13. NERLYNX Thailand Product Information.

14. NERLYNX (neratinib) European Summary of Product Characteristics.

15. Hamilton E, et al. Cancer Treat Rev 2021;100;102286,

16. Yang J, et al. Comput Struct Biotechnol J 2021;20:333-342.

17. Chan A, et al. Clin Breast Cancer 2021;21(1):80-91.e7.