On June 22, 2022, the #FDA granted an accelerated approval to #dabrafenib in combination with #trametinib for treatment of adult and pediatric patients (aged 6 and older) with unresectable or metastatic solid tumors with #BRAF V600E mutation whose disease progressed following prior treatment and who have no other satisfactory treatment options.

The approval was based on findings from several trials that collectively included 131 adults and 36 pediatric patients. Among the 131 adults, an objective response was observed in 54 patients (41%). Among the 36 pediatric patients, an objective response was observed in 9 (25%). The most common side effects were pyrexia, fatigue, nausea, and rash.

Of note, this combination is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.