#Thailand #Bangkok #NERLYNX #HER2+

Introduction

In a momentous development for women's health, Thailand has recently approved a new therapy aimed at combating breast cancer, specifically targeting those with human epidermal growth factor receptor 2 positive (HER2+) breast cancer. The introduction of NERLYNX® (neratinib) marks a significant advancement for eligible women across the nation, offering renewed hope and more effective treatment options in their battle against this aggressive form of cancer.

Overview of NERLYNX

NERLYNX is an innovative oral medication that has been shown to notably reduce the risk of recurrence and enhance disease-free survival rates among women who have been diagnosed with HER2+ breast cancer. The therapy was sanctioned by the Thai FDA in December 2024, signaling a critical addition to the therapeutic landscape for breast cancer management. It is approved for two distinct patient populations:
1. As a single agent for the extended adjuvant treatment of women with early-stage hormone receptor-positive HER2-overexpressed/amplified breast cancer.
2. In combination with capecitabine for patients with advanced or metastatic HER2+ breast cancer, who have previously undergone two or more anti-HER2 therapy regimens.

The Need for New Treatment Options

Breast cancer remains the most prevalent cancer among Thai women, with staggering statistics revealing over 20,000 new diagnoses each year and more than 4,800 fatalities attributed to the disease. Approximately 15-25% of all breast cancer cases exhibit HER2+ characteristics, which are typically associated with more severe disease progression and increased recurrence risk. Prior therapies, such as trastuzumab, while effective, still leave a significant number of women at risk for relapse, with around 26% of HER2+ patients experiencing disease recurrence.

Dr. Bhuvana Ramaswamy, the ST Medical Lead for Southeast Asia, expressed the importance of NERLYNX's introduction: "The availability of this treatment is particularly crucial for patients with early or metastatic HER2+ breast cancer, providing an additional weapon against this dreadful disease that directly addresses the ongoing risk of progression and recurrence."

Efficacy and Safety of NERLYNX

Research has shown that NERLYNX significantly lowers the risk of recurrence in women who are hormone-receptor positive and begin therapy shortly after completing trastuzumab treatment. In fact, the five-year risk of recurrence can be reduced by up to 42% in this patient group.

For women with more advanced stages of the disease, the combination of NERLYNX with capecitabine demonstrated a marked increase in progression-free survival (PFS), with an average increase of 2.2 months compared to existing therapies. Moreover, NERLYNX proved to extend the duration of treatment response, with median PFS lasting longer than with previous regimens.

Specialised Therapeutics' Role

The drug is being made available by Specialised Therapeutics (ST), an independent pharmaceutical firm committed to improving cancer care in the region. Mr. Carlo Montagner, CEO of ST, highlighted their dedication to meeting the needs of Thai oncologists for improved treatment options. He stated: "We are excited to offer this innovative therapy to eligible patients for the first time, as it plays a vital role in preventing disease recurrence."

Furthermore, ST has initiated local outreach efforts through a dedicated field team to foster relationships with oncologists across Thailand, ensuring healthcare professionals are well-informed about this new therapy.

Rising Breast Cancer Incidences

The rising rate of breast cancer in Thailand is alarming, having doubled over the past two decades. In 2022, breast cancer constituted nearly a quarter of all new cancer diagnoses among Thai women, underscoring the pressing need for effective treatments like NERLYNX.

Conclusion

The introduction of NERLYNX in Thailand is not just a medical advancement; it is a beacon of hope for women fighting HER2+ breast cancer. With improved options on the horizon, the fight against breast cancer in Thailand takes a significant step forward, potentially transforming the lives of many patients and their families. Continued research, awareness, and innovations in treatment are crucial in the ongoing battle against breast cancer, and the launch of NERLYNX represents a promising new chapter in this effort.