Dabrafenib Plus Trametinib Approved For Unresectable or Metastatic BRAF V600E Mutations

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...

Continue reading

High-Risk Melanoma: Dabrafenib/Trametinib Preserves Quality of Life While Preventing Relapse

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...

Continue reading

Metastatic Melanoma: Dabrafenib/Trametinib Improves Outcomes

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...

Continue reading

Copyright © 2022 Oncology Data Advisor. All rights reserved.