Posted by Michael Wonder on 23 Jun 2022
Novartis Tafinlar and Mekinist receives FDA approval for first tumour agnostic indication for BRAF V600E solid tumours
22 June 2022 - Approval supported by results from Phase II ROAR and NCI-MATCH studies demonstrating overall response rates up to 80% in patients with BRAF V600E solid tumours.
Novartis today announced the US FDA granted accelerated approval for Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of adult and paediatric patients 6 years of age and older with unresectable or metastatic solid tumours with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
