Novartis’ Tafinlar® + Mekinist® New Indication Approved, Offering a New Precision Treatment Option for BRAF V600E Mutation-Positive RAIR-DTC Patients

ShanghaiJune 10, 2026 /PRNewswire/ — Novartis today announced that its dual-target combination therapy, Tafinlar^® (dabrafenib mesylate capsules) in combination with Mekinist^® (trametinib tablets), has received approval from the National Medical Products Administration for a new indication. This approval is for the treatment of adult patients with BRAF V600E mutation-positive, radioactive iodine-refractory or ineligible, and vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI)-treated failure locally advanced or metastatic differentiated thyroid cancer. This is the fourth indication approved in China for Tafinlar^® in combination with Mekinist^®, marking a new precision targeted therapy option for patients with BRAF V600E mutation-positive radioactive iodine-refractory differentiated thyroid cancer (hereinafter referred to as RAIR-DTC).

This new indication approval is based on a Phase III clinical trial led by a Chinese research center, involving multiple centers across the globe, with extensive enrollment of Asian patients. The study showed that compared to the placebo group, the dabrafenib combined with trametinib treatment group significantly extended median progression-free survival (mPFS) to 12.8 months, an increase of 9.1 months over the placebo group’s 3.7 months, reducing the risk of disease progression or death by 62%. The objective response rate (ORR) was as high as 57.4%, compared to 3.8% in the placebo group, demonstrating significant tumor shrinkage benefits. Overall survival (OS) data are not yet fully mature but show a trend toward benefit. In terms of safety, no new safety signals were observed in the combination treatment group^[1].

Li Yao, President and Managing Director of Novartis China, stated: “Novartis has long been deeply involved in the oncology field, continuously focusing on the unmet treatment needs of Chinese patients. The approval of this new indication for dabrafenib combined with trametinib is a significant reflection of the implementation of globally leading research results led by Chinese clinical scholars in China, bringing a long-awaited new precision treatment option for patients with BRAF V600E mutation-positive RAIR-DTC. In the future, Novartis will continue to uphold the concept of ‘Commitment to China,’ deepen cooperation with the local innovation ecosystem, and accelerate the delivery of global cutting-edge medical achievements to benefit more Chinese patients.”

Focusing on the Treatment Dilemma of RAIR-DTC, Advancing Precision Treatment for Thyroid Cancer

In recent years, the incidence of thyroid cancer has been on the rise globally, and it has become one of the more common malignant tumors in China. According to data released on the prevalence of malignant tumors in China in 2024^[2], thyroid cancer ranks second in incidence. Differentiated thyroid cancer (DTC) is the most common type, accounting for over 95% of all thyroid cancer cases^[3]. Although the overall prognosis for DTC is good, once the disease progresses to the radioactive iodine-refractory (RAIR) stage with distant metastasis, the patient’s 5-year survival rate significantly decreases, creating a severe clinical challenge.

The BRAF V600E mutation is the most frequent driver gene alteration in differentiated thyroid cancer, especially papillary thyroid cancer, with an incidence rate as high as 86%^[4]. This mutation continuously activates the MAPK signaling pathway, promoting abnormal tumor cell proliferation while inhibiting the expression of the sodium-iodide symporter (NIS), leading to a gradual loss of iodine uptake ability in tumor cells. This is one of the key mechanisms driving some patients to progress to RAIR-DTC^[5-6].

Professor Gao Ming, from the First Affiliated Hospital of Nankai University and Chairman of the Thyroid Cancer Professional Committee of the Chinese Anti-Cancer Association, stated: This approval is based on the first global multicenter Phase III DTC trial led by China, confirming that dabrafenib combined with trametinib provides clear clinical benefits and manageable safety for these patients. The significance of this treatment regimen’s approval extends beyond adding an effective option for late-stage treatment; it strongly validates the core value of integrating molecular testing deeply into the full-process patient management of DTC diagnosis and treatment, driving DTC treatment towards greater precision and individualization.

Dual-Target Synergy Blocks the MAPK Pathway, Directly Targeting Core Driver Mutations

Dabrafenib combined with trametinib employs a dual-target inhibition strategy: dabrafenib targets and inhibits the BRAF V600E mutation, blocking the transmission of abnormal proliferation signals downstream; trametinib acts on the downstream MEK pathway. The two synergistically inhibit the MAPK signaling pathway, thereby suppressing tumor cell proliferation, inducing apoptosis, and reducing tumor invasiveness, providing a precise treatment pathway for patients carrying the BRAF V600E mutation.

For a long time, systemic treatment for radioactive iodine-refractory differentiated thyroid cancer has primarily relied on multi-target tyrosine kinase inhibitors (mTKIs). Although these drugs can extend progression-free survival (PFS) compared to traditional chemotherapy, some patients still face challenges such as limited subsequent treatment options and prominent safety issues after treatment failure, highlighting an urgent clinical need for further solutions^[1]. With the in-depth application of molecular testing and precision oncology concepts in thyroid cancer diagnosis and treatment, implementing individualized treatment targeting specific driver gene alterations is becoming an important direction for improving patient outcomes.

The approval of this new indication for Tafinlar^® in combination with Mekinist^® not only brings a new treatment option for patients with BRAF V600E mutation-positive radioactive iodine-refractory differentiated thyroid cancer but also further enriches the clinical practice pathways for precision treatment of thyroid cancer in China. In the future, Novartis will continue to collaborate with clinical experts, research institutions, and healthcare ecosystem partners to promote the accessibility of innovative therapies, helping more patients achieve longer-term and higher-quality survival benefits.

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