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.

Read Novartis press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US