Novartis' BRAF/MEK Combination Tafinlar + Mekinist Receives FDA Approval for Expanded Pan-Tumor Indication in Patients Aged 1 and Older with BRAF V600E-Mutant Solid Tumors

Recently, the FDA's official website showed that Novartis' Tafinlar (dabrafenib) + Mekinist (trametinib) combination has been approved for expanded indications, with the applicable population now expanded to1 year and above (originally 6 years and above)Unresectable or metastatic with BRAF V600E mutationSolid TumorPatients who have previously received treatment and experienced disease progression, and for whom there are no satisfactory alternative treatment options.

Latest Dabrafenib Instructions (Source: FDA Official Website)

Tafinlar+Mekinist is the first and only BRAF/MEK inhibitor combination approved for the treatment of BRAF V600E mutation-positive solid tumors across cancer types, and it is also the only BRAF/MEK inhibitor combination approved for pediatric patients (see: ).

BRAF mutations have been identified as a driver of growth in various solid tumors, including rare cancer types that are difficult to study in phase III trials and often have limited treatment options. BRAF V600E is the most common type of BRAF mutation, accounting for 90% of BRAF-mutated cancers, and can drive tumor growth in more than 20 different cancer types.

In the previously published Phase II ROAR basket study and NCI-MATCH Subprotocol H study, Tafinlar + Mekinist showed an overall response rate of up to 80% in patients with BRAF V600E-mutant solid tumors, including high-grade and low-grade gliomas, biliary tract cancer, and certain gynecological and gastrointestinal cancers. Another study (Study X2101) also demonstrated the clinical benefits and acceptable safety profile of Tafinlar + Mekinist in pediatric patients.

The safety of Tafinlar + Mekinist observed in these studies is consistent with the known safety profile for its other approved indications.

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