dabrafenib

dabrafenib

None

NSCLC

Dabrafenib was approved by the FDA May 29, 2013 for the treatment of metastatic or unresectable melanoma.

June 30, 2017 FDA granted regular approvals to dabrafenib and trametinib (Tafinlar and Mekinist) administered in combination for patients with metastatic non-small cell lung cancer with BRAF V600E mutation as detected by an FDA-approved test. The two agents, sponsored by Novartis, are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.

5/4/2018 The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).

June 24, 2022 FDA has granted accelerated approval to Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.

March 16, 2023 FDA approved dabrafenib (Tafinlar) with trametinib (Mekinist), for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.

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