Symbolic image of a path from darkness to light representing melanoma treatment success.

Hope for Melanoma Patients: NICE Recommends Dabrafenib and Trametinib

Elliot Brynn in Health & Wellness November 2025 • 4 min read.

"A New Treatment Option Approved for Stage III BRAF V600 Mutation-Positive Melanoma"

In a significant stride forward for melanoma treatment, the UK National Institute for Health and Care Excellence (NICE) has given its nod of approval to the combination of dabrafenib and trametinib as an adjuvant treatment for stage III BRAF V600 mutation-positive melanoma. This recommendation offers a beacon of hope for patients whose melanoma has spread to nearby lymph vessels or lymph glands, a stage where treatment options have been historically limited.

This decision marks a crucial turning point in the management of melanoma, providing a new and effective tool for healthcare professionals in their fight against this aggressive skin cancer. The approval underscores the commitment of NICE to ensuring that patients in the UK have access to the most innovative and beneficial treatments available.

The combined therapy, developed by Novartis, has shown promising results in clinical trials, leading to its recommendation as a standard of care for eligible patients. This marks a significant advancement in how melanoma is treated and managed, potentially improving outcomes and quality of life for those affected.

Why This Recommendation Matters for Melanoma Patients

Symbolic image of a path from darkness to light representing melanoma treatment success.

Prior to this recommendation, individuals diagnosed with stage III BRAF V600 mutation-positive melanoma faced a landscape with very few adjuvant treatment options. The approval of dabrafenib plus trametinib fills a critical unmet need, offering a targeted therapy that has demonstrated the ability to significantly improve outcomes.

Mirella Marlow, deputy director for the NICE Centre for Health Technology Evaluation, emphasized the importance of this decision, stating, "We are therefore delighted that we were able to work with the company and NHS England to recommend dabrafenib plus trametinib as a new treatment option, marking an important development in the management of melanoma."

Targeted Treatment: Specifically addresses melanoma with the BRAF V600 mutation.
Adjuvant Therapy: Used after surgery to reduce the risk of recurrence.
Improved Outcomes: Clinical trials have shown a significant improvement in recurrence-free survival.

The availability of dabrafenib plus trametinib provides a much-needed option for patients and their families, offering hope for a better prognosis and improved overall survival. This decision by NICE reflects a commitment to incorporating cutting-edge treatments into the UK healthcare system.

Access and Administration of Dabrafenib Plus Trametinib

Dabrafenib plus trametinib will be accessible at a confidential discounted price agreed upon between NHS England and the drug company, ensuring that the treatment is available to those who need it. The drugs are administered orally, twice daily and once daily, respectively, making it a convenient option for patients.

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Everything You Need To Know

What is the significance of NICE approving dabrafenib plus trametinib for melanoma treatment?

The approval by the UK's National Institute for Health and Care Excellence (NICE) of dabrafenib combined with trametinib represents a major advancement in the treatment of stage III BRAF V600 mutation-positive melanoma. Previously, patients with this specific type of melanoma, which has spread to nearby lymph vessels or glands, had limited treatment options. This decision offers a new, effective adjuvant therapy, potentially improving outcomes and quality of life for affected individuals by targeting the BRAF V600 mutation. This is particularly important because adjuvant therapy is given after surgery to help prevent the cancer from returning.

How do dabrafenib and trametinib work together to treat melanoma?

Dabrafenib and trametinib are targeted therapies that specifically address melanoma with the BRAF V600 mutation. Dabrafenib inhibits the BRAF protein, while trametinib inhibits the MEK protein, which is downstream of BRAF in the signaling pathway. By inhibiting both proteins, the combination of dabrafenib and trametinib effectively blocks the growth and spread of melanoma cells that harbor the BRAF V600 mutation. This dual inhibition is more effective than inhibiting either protein alone. However, it's important to note that this treatment is only effective for melanomas with the BRAF V600 mutation and will not work for melanomas without this mutation.

Who is eligible to receive treatment with dabrafenib plus trametinib?

Dabrafenib plus trametinib is specifically approved as an adjuvant treatment for patients with stage III BRAF V600 mutation-positive melanoma. This means that the melanoma must have spread to nearby lymph vessels or lymph glands, and a genetic test must confirm the presence of the BRAF V600 mutation within the melanoma cells. Patients typically receive this treatment after undergoing surgery to remove the primary melanoma and affected lymph nodes. The goal of the therapy is to reduce the risk of the melanoma recurring. Patients with other stages of melanoma or those without the BRAF V600 mutation are not eligible for this treatment.

How will patients access dabrafenib plus trametinib in the UK, and what is the administration like?

Dabrafenib plus trametinib will be accessible to eligible patients in the UK through NHS England, with a confidential discounted price agreed upon with the drug company. This ensures that the treatment is available to those who need it. The drugs are administered orally, with dabrafenib taken twice daily and trametinib taken once daily. The oral administration route offers convenience for patients, allowing them to take the medication at home, which can improve their quality of life during treatment. However, patients must adhere to the prescribed dosage and schedule to ensure the treatment's effectiveness.

What outcomes can patients expect from treatment with dabrafenib plus trametinib, and what factors can influence these outcomes?

Clinical trials have demonstrated that treatment with dabrafenib plus trametinib significantly improves recurrence-free survival in patients with stage III BRAF V600 mutation-positive melanoma. This means that patients receiving this adjuvant therapy have a lower risk of their melanoma returning after surgery. While the therapy offers hope for improved outcomes, the success of the treatment can be influenced by various factors, including the stage and extent of the melanoma at diagnosis, the patient's overall health, and adherence to the treatment regimen. Regular monitoring and follow-up are essential to assess the treatment's effectiveness and manage any potential side effects.