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

Puma Biotechnology (NASDAQ: PBYI) licensed NERLYNX® (neratinib) is now available in Thailand via Specialised Therapeutics following Thai FDA approval in December 2024.

Rhea-AI Summary

Puma Biotechnology (NASDAQ: PBYI) licensed NERLYNX® (neratinib) is now available in Thailand via Specialised Therapeutics following Thai FDA approval in December 2024.

NERLYNX is approved as a single agent for extended adjuvant treatment of early-stage HR+ HER2+ breast cancer within 12 months of completing trastuzumab, and with capecitabine for advanced/metastatic HER2+ disease after two or more prior anti-HER2 regimens.

Clinical data cited include a reduction in five-year recurrence risk by up to 42% in early-stage HR+ patients and, in advanced disease, a 2.2-month mean PFS improvement and longer response duration (8.5 vs 5.6 months) with NERLYNX+capecitabine versus lapatinib+capecitabine.

Positive

• Thai FDA approval granted in December 2024
• Five-year recurrence risk reduced by up to 42% in HR+ early-stage patients
• PFS +2.2 months for NERLYNX+capecitabine versus lapatinib+capecitabine
• Longer treatment response: 8.5 vs 5.6 months (N+C vs L+C)
• Risk of progression/death reduced by up to 24% at 30-month median follow-up

Negative

• Estimated 26% recurrence rate after trastuzumab highlights unmet need
• Early-stage benefit concentrated in patients starting NERLYNX within 12 months of trastuzumab

Argus Jan 22 session

-0.44% close to close 2.0x rel. volume Open Argus

Details

News Market Reaction – PBYI

On Jan 22, the day this news came out, PBYI closed 0.44% below the previous close. That session’s volume was 2.0x the stock’s average daily volume.

Data tracked by StockTitan Argus for the Jan 22 session.

Key Figures

HER2+ prevalence: 15–25% Recurrence after trastuzumab: 26% Recurrence risk reduction: 42% +5 more

HER2+ prevalence

15–25%

Proportion of all breast cancer tumours that are HER2+

Recurrence after trastuzumab

26%

HER2+ breast cancer patients with disease recurrence post-trastuzumab

Recurrence risk reduction

42%

Five-year recurrence risk reduction in eligible HR+ HER2+ patients on NERLYNX

PFS improvement

2.2 months

Mean PFS gain for NERLYNX + capecitabine vs lapatinib + capecitabine

Response duration N+C

8.5 months

Duration of treatment response with NERLYNX + capecitabine

Response duration L+C

5.6 months

Duration of treatment response with lapatinib + capecitabine

Progression/death risk reduction

24%

Risk reduction with NERLYNX + capecitabine at 30-month follow-up

Breast cancer share

23.2%

Share of all new cancer diagnoses in Thai women in 2022

Historical Context

5 past events · Latest: Jan 07

5 events

1. Jan 07

   Inducement awards

   24h Move

   +1.8%

   RSU inducement grants for three new non-executive employees.

2. Dec 22

   Index inclusion

   24h Move

   +1.4%

   Added to Nasdaq Biotechnology Index reflecting commercial and clinical progress.

3. Dec 02

   Inducement award

   24h Move

   +6.6%

   Single RSU inducement grant to a new non-executive employee.

4. Nov 07

   Inducement awards

   24h Move

   -21.0%

   RSU inducement awards for two new non-executive employees.

5. Nov 06

   Earnings update

   24h Move

   -0.9%

   Profitable Q3 2025 results and raised full‑year revenue and income guidance.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

her2+, trastuzumab, metastatic, capecitabine, +4 more

8 terms

her2+ medical

"women diagnosed with human epidermal growth factor receptor 2 positive (HER2+) breast cancer"

HER2+ means a tumor has abnormally high levels or extra copies of the HER2 protein, a growth receptor on cell surfaces; imagine cells with extra antennae picking up signals that make them divide faster. For investors, HER2+ status defines a clear market for targeted drugs and diagnostic tests, shaping clinical trial needs, regulatory approvals, treatment adoption, and therefore potential revenue and valuation for companies involved in therapies or tests.

trastuzumab medical

"who completed adjuvant trastuzumab-based therapy less than one year ago"

Trastuzumab is a targeted cancer medicine that binds to a specific protein on certain tumor cells and helps stop their growth, like a guided missile that finds one type of enemy cell rather than a broad shotgun approach. It matters to investors because regulatory approvals, patent status, pricing and competition from copies (biosimilars) strongly affect sales and profitability, and changes in clinical results or label expansions can move a company’s stock.

metastatic medical

"for the treatment of adult patients with advanced or metastatic HER2+ breast cancer"

Metastatic describes cancer that has spread from its original spot to other organs or tissues, like weeds moving from one garden bed into several others. For investors, metastatic disease matters because it often requires more complex, long-term treatments, larger clinical trials, and can drive demand for specialized drugs and diagnostics—factors that affect a drug’s development costs, regulatory risk, market size, and potential revenue.

capecitabine medical

"In combination with capecitabine "for the treatment of adult patients with advanced"

An oral chemotherapy prodrug that converts in the body into an active cancer-fighting agent similar to 5-fluorouracil; think of it as a timed-release package that becomes active after swallowing. It matters to investors because its use, safety profile, patent status and competition from generics or alternative treatments directly affect sales, clinical-program value and regulatory risk for companies involved in oncology medicines.

lapatinib medical

"over treatment with lapatinib plus capecitabine (L+C)"

Lapatinib is an oral targeted cancer medicine that blocks growth signals from two proteins (HER2 and EGFR) that can drive some tumors, especially certain breast cancers, to grow. For investors it matters because clinical trial results, regulatory approvals, side-effect profiles, patent life and competing therapies determine the drug’s commercial prospects and potential revenue—think of it as a company product whose market value depends on effectiveness, safety and exclusive rights.

progression-free survival medical

"helping to improve progression free survival," said Dr Ramaswamy"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

hormone receptor positive medical

"early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer"

Hormone receptor positive describes cancers whose cells have proteins on their surface that act like locks for specific hormones (commonly estrogen or progesterone); when the hormone keys fit, they can tell the cell to grow. For investors this matters because such tumors are often treatable with drugs that block or alter hormone signals, so a cancer being hormone receptor positive changes the likely treatment options, size of the addressable patient group, clinical trial design, and potential market value for therapies and diagnostics.

disease-free survival medical

"therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival"

Disease-free survival measures the length of time after treatment during which a patient shows no signs or symptoms of the disease. For investors, it is a key clinical result because longer disease-free periods suggest a therapy is effective at preventing recurrence, which can drive regulatory approval, market demand and revenue potential—think of it as how long a repaired item runs without breaking down.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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.

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SOURCE Specialised Therapeutics

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What approvals did NERLYNX (PBYI) receive from the Thai FDA and when?

Thai FDA approved NERLYNX in December 2024 for extended adjuvant use in early-stage HR+ HER2+ disease and with capecitabine for advanced/metastatic HER2+ disease.

How much does NERLYNX reduce five-year recurrence risk for early-stage HR+ HER2+ patients?

NERLYNX reduced the five-year recurrence risk by up to 42% in HR+ early-stage patients who start treatment within 12 months of finishing trastuzumab.

What is the progression-free survival benefit of NERLYNX plus capecitabine in advanced HER2+ cancer?

NERLYNX plus capecitabine improved mean PFS by 2.2 months versus lapatinib plus capecitabine, with longer response duration (8.5 vs 5.6 months).

Which patients in Thailand are eligible for NERLYNX as an extended adjuvant treatment?

Adult patients with early-stage HR+ HER2+ breast cancer who completed trastuzumab-based adjuvant therapy less than one year ago.

Who will supply NERLYNX in Thailand and under what arrangement?

Specialised Therapeutics will make NERLYNX available in Thailand under an exclusive license from Puma Biotechnology (PBYI).