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...

Previously, the researchers of the phase 3 COMBI-AD study found that adjuvant combination therapy consisting of dabrafenib (Taflinar®, Novartis) plus trametinib (Mekinist®, Novartis) helped to prevent relapse in patients with high-risk BRAF V600–mutant melanoma after surgical resection. The investigators now report that dabrafenib/trametinib combination therapy also helps to maintain quality of life. A targeted therapy drug, trametinib is an MEK inhibitor that works by targeting the MEK 1 and ME...

Historically, patients with metastatic melanoma have a poor prognosis. However, due to the development of BRAF- and MEK-targeted therapies, patient outcomes have improved. To further characterize the outcomes associated with these treatments, researchers compiled and analyzed data from two clinical trials and found that in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, dabrafenib plus trametinib had many long-term benefits in about one third of patients. D...