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FDA grants accelerated approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for first tumor-agnostic indication for BRAF V600E solid tumors

27 Jun 2022 9:02 AM | Katy Monaco (Administrator)
The Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) 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. Dabrafenib in combination with trametinib is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for patients with wild-type BRAF solid tumors. More Information

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