The FDA has granted approval to dabrafenib (Tafinlar®, Novartis) with trametinib (Mekinist®, Novartis) for treatment of pediatric patients with BRAF V600E–mutated low-grade glioma (LGG) who require systemic therapy. In addition, the FDA approved new oral formulations of dabrafenib and trametinib for patients who cannot swallow pills. This is notable as it is the first approval of a systemic therapy in a first-line setting for pediatric patients with BRAF V600E–mutated LGG. "LGG is the most commo...

The FDA has given accelerated approval to dabrafenib (Tafinlar®, Novartis) in combination with trametinib (Mekinist®, Novartis) for treatment of adult or pediatric patients with unresectable or metastatic solid tumors with a BRAF V600E mutation and no satisfactory alternative treatment options. This approval is based on three clinical trials: the Rare Oncology Agnostic Research (ROAR) phase 2 basket study, the NCI-MATCH Subprotocol H study, and Study X2101 which was specific to the enrollment of...

After patients with metastatic colorectal cancer who have a BRAF V600E mutation stop responding to first-line treatment, they have a median survival of only four to six months. These patients now have a new option in a combination therapy consisting of encorafenib (Braftovi®, Array BioPharma) and cetuximab (Erbitux®, Lilly), which was approved by the FDA earlier this month for adults with previously treated BRAF V600E-mutated metastatic colorectal cancer. In this interview with i3 Health, Scott ...

An updated analysis of a phase 3 trial reports that encorafenib/cetuximab, alone or in combination with binimetinib, improves quality of life compared with the current standard of care in patients with BRAF V600E-mutant metastatic colorectal cancer whose disease progressed after one or two prior therapies. The BEACON CRC study, the results of which were published in the New England Journal of Medicine in October, investigated the efficacies of encorafenib/cetuximab/binimetinib (triplet therapy) ...