Us Fda Granted Accelerated Approval To Novartis Tafinlar + Mekinist For First Tumour-Agnostic Indication For Braf V600E Solid Tumours

Us Fda Granted Accelerated Approval To Novartis Tafinlar + Mekinist For First Tumour-Agnostic Indication For Braf V600E Solid Tumours

By, Admin 25 June 2022

Novartis Announced The Us Food And Drug Administration (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. In Accordance With The Accelerated Approval Programme, Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S). Tafinlar + Mekinist Is The First And Only Braf/Mek Inhibitor To Be Approved With A Tumour-Agnostic Indication For Solid Tumours Carrying The Braf V600E Mutation, Which Drives Tumour Growth In More Than 20 Different Tumour Types, And It Is The Only Braf/Mek Inhibitor Approved For Use In Paediatric Patients.

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