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Novartis: FDA OKs Tafinlar + Mekinist For Solid Tumors With BRAF V600E Mutation

Swiss drug major Novartis AG (NVS) announced Thursday that the US Food and Drug Administration or FDA granted accelerated approval for Tafinlar (dabrafenib) + Mekinist (trametinib) to treat unresectable or metastatic solid tumors with BRAF V600E mutation.

The company noted that Tafinlar + Mekinist is the first and only BRAF/MEK inhibitor therapy to be approved with a tumor-agnostic indication for patients with solid tumors that have a BRAF V600E mutation, who have progressed following prior treatment and have no satisfactory alternative treatment options. It is also the only BRAF/MEK inhibitor approved for use in pediatric patients 6 years of age and older.

BRAF mutations drive tumor growth across more than 20 tumor types, including thyroid, brain and gynecologic cancers.

The FDA approval was based on clinical efficacy and safety demonstrated in three clinical trials. Results from Phase II ROAR and NCI-MATCH studies demonstrated overall response rates up to 80% in patients with BRAF V600E solid tumors. An additional study (Study X2101) demonstrated the clinical benefit and acceptable safety profile of Tafinlar + Mekinist in pediatric patients.

The company noted that the safety profile of Tafinlar + Mekinist observed in these studies was consistent with the known safety profile in other approved indications.

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