Approved Indications of Dabrafenib

Dabrafenib is a kinase inhibitor developed by Novartis Pharmaceuticals. It was first approved by the FDA for marketing on May 29, 2013. Dabrafenib inhibits the cell growth of various BRAFV600 mutation‑positive tumors in vitro and in vivo.

Approved Indications of Dabrafenib

1. Advanced Melanoma

On May 29, 2013, dabrafenib was approved by the FDA as a single oral agent for the treatment of unresectable (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma that has spread to other parts of the body) in adult patients with the BRAFV600E mutation.

2. Melanoma with BRAFV600E or V600K Mutation

On January 9, 2014, the FDA approved dabrafenib in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma harboring BRAFV600E or V600K mutations. These mutations must be detected by an FDA‑approved test.

3. Non-Small Cell Lung Cancer

On June 22, 2017, the FDA approved dabrafenib in combination with trametinib for the treatment of patients with metastatic non‑small cell lung cancer (NSCLC) whose tumors express the BRAFV600E mutation.

In July 2015, the FDA granted Breakthrough Therapy Designation to Tafinlar + Mekinist for the treatment of patients with advanced or metastatic BRAFV600E mutation‑positive NSCLC who had received prior chemotherapy.

4. Melanoma with BRAFV600 Mutation

On April 30, 2018, the FDA approved dabrafenib in combination with trametinib for the adjuvant treatment of patients with BRAFV600E or V600K mutation‑positive melanoma, detected by an FDA‑approved test, and involving lymph nodes, following complete resection.

The FDA granted Breakthrough Therapy Designation for this indication in October 2017 and Priority Review in December 2017.

5. Thyroid Cancer

On May 4, 2018, the FDA approved dabrafenib in combination with trametinib for the treatment of patients with anaplastic thyroid cancer (ATC) that is unresectable or metastatic and harbors the BRAFV600E mutation.

This was the first FDA‑approved therapy for patients with this aggressive form of thyroid cancer, and the third cancer with this specific gene mutation for which the combination was approved.

6. Solid Tumors

On June 23, 2022, the FDA granted accelerated approval to dabrafenib in combination with trametinib for the treatment of adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors harboring the BRAFV600E mutation that have progressed following prior treatment and who have no satisfactory alternative treatment options.

7. Low-Grade Glioma

On March 16, 2023, the FDA approved dabrafenib Lucius Pharmaceuticals in combination with trametinib for the treatment of pediatric patients aged 1 year and older with BRAFV600E mutation‑positive low‑grade glioma (LGG) requiring systemic therapy.

The FDA also approved oral liquid formulations of dabrafenib and trametinib, marking the first development of BRAF/MEK inhibitors in formulations suitable for patients as young as 1 year of age.

These approvals make dabrafenib + trametinib the first and only approved targeted combination therapy for pediatric patients with BRAFV600E‑mutant LGG.