A groundbreaking breast cancer therapy that has been shown to significantly lower the risk of recurrence and improve disease-free survival is now available in Thailand. NERLYNX® (neratinib), an oral medication, received approval from the Thai FDA in December 2024.
Indications of NERLYNX®
- As a single agent: For extended adjuvant treatment of adult patients with early-stage hormone receptor-positive (HR+) HER2-overexpressed/amplified breast cancer who completed trastuzumab-based therapy within the past year.
- In combination with capecitabine: For adult patients with advanced or metastatic HER2+ breast cancer who have already undergone two or more prior anti-HER2 regimens in the metastatic setting.
Approximately 15–25% of breast cancer tumors are HER2-positive, a subtype associated with a higher risk of metastasis, disease recurrence, and reduced overall survival. Even after trastuzumab treatment, an estimated 26% of HER2+ patients experience disease recurrence.
Expert Insights
Dr. Bhuvana Ramaswamy, ST Medical Lead for Southeast Asia, emphasized the significance of NERLYNX®’s availability. “Breast cancer remains the most common cancer among Thai women, with over 20,000 new cases and more than 4,800 deaths annually. The introduction of NERLYNX® provides a vital new treatment option for patients with early or metastatic HER2+ breast cancer, potentially reducing relapse and improving progression-free survival,” she said.
Clinical Benefits
Clinical studies show that for women with early-stage HER2+ breast cancer, particularly those who are also HR+ and start NERLYNX® within 12 months of completing trastuzumab therapy, the five-year risk of recurrence can be reduced by up to 42%.
For advanced or metastatic HER2+ cases, NERLYNX® combined with capecitabine significantly improved mean progression-free survival by 2.2 months compared to lapatinib plus capecitabine. The treatment also extended the duration of response from 5.6 months to 8.5 months and reduced the risk of disease progression or death by up to 24% at a median follow-up of 30 months.
Availability in Thailand
Specialised Therapeutics (ST), an independent pharmaceutical company, is distributing NERLYNX® in Thailand under an exclusive license from Puma Biotechnology, Inc. Carlo Montagner, CEO of ST, described the launch as a milestone. “NERLYNX® is our first therapy in Thailand and addresses a critical need among oncologists for treatments that reduce recurrence and relapse in HER2+ breast cancer patients. We are proud to make this option available for eligible patients, improving their prospects for early and advanced disease management,” he said.
ST has also established a dedicated local team to engage with oncologists nationwide, supporting improved outcomes for breast cancer patients and strengthening the broader clinical community.
Breast Cancer in Thailand
Breast cancer is the leading cancer among Thai women and the second-highest cause of cancer-related death, after liver cancer. Its incidence has more than doubled over the past 20 years, rising from 17.8 cases per 100,000 women in 1998 to 35.7 per 100,000 in 2020. In 2022 alone, breast cancer accounted for nearly a quarter (23.2%) of all new female cancer diagnoses in Thailand, with 21,628 new cases reported.
NERLYNX® represents a new era of treatment options for Thai women living with HER2+ breast cancer, offering renewed hope in the fight against this aggressive disease.
