Dabrafenib is a kinase inhibitor developed by Novartis and first received FDA approval on May 29, 2013. Dabrafenib inhibits cell growth in various BRAFV600 mutation-positive tumors both in vitro and in vivo.
Approved Indications for Dabrafenib:
1. Advanced Melanoma:
On May 29, 2013, the FDA approved dabrafenib as a monotherapy for the oral treatment of unresectable melanoma (melanoma that cannot be surgically removed) or metastatic melanoma (melanoma that has spread to other parts of the body) in adult patients with BRAFV600E mutations.
2. BRAF V600E or V600K Mutant Melanoma
On January 9, 2014, the FDA approved dabrafenib in combination with trametinib for the treatment of patients with unresectable melanoma (melanoma that cannot be surgically removed) or metastatic melanoma (melanoma that has spread to other parts of the body) harboring BRAF V600E or V600K mutations. These mutations must be detected using 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 BRAF V600E mutation. In July 2015, the FDA granted Tafinlar + Mekinist Breakthrough Therapy designation for the treatment of patients with advanced or metastatic BRAF V600E-mutant positive NSCLC who have previously received chemotherapy.
4. BRAFV600 Mutant Melanoma
On April 30, 2018, the FDA approved dabrafenib in combination with trametinib as adjuvant therapy for patients with BRAFV600E or V600K mutant melanoma, as detected by FDA-approved testing, and with lymph node involvement, after complete resection. The FDA granted this indication Breakthrough Therapy designation in October 2017 and Priority Review in December 2017.
5. Thyroid Cancer
On May 4, 2018, the FDA approved dabrafenib and trametinib in combination for the treatment of undifferentiated thyroid carcinoma (ATC) that is unresectable or has spread to other parts of the body (metastatic) and has an abnormal gene, BRAFV600E (BRAFV600E mutation positive). This is the first FDA-approved treatment for this type of aggressive thyroid cancer and the third cancer with this specific gene mutation that has been approved for this drug combination.
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 of the BRAF V600E mutation who have progressed after prior therapy and have no satisfactory alternative treatment options.
7. Low-Grade Gliomas
On March 16, 2023, the FDA approved dabrafenib in combination with trametinib for the treatment of pediatric patients aged 1 year and older with BRAF V600E-mutant low-grade gliomas (LGG) who require systemic therapy. The FDA also approved the liquid formulation of dabrafenib and trametinib, marking the first time a BRAF/MEK inhibitor has been developed with a formulation suitable for patients as young as one year old. These approvals make dabrafenib + trametinib the first and only approved combination targeted therapy for the treatment of pediatric patients with BRAF V600E LGG.
