> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Accelerated Approval for Novartis Combo Therapy
- URL: https://www.fdaweb.com/accelerated-approval-for-novartis-combo-therapy/
- Published: 2022-06-23T12:00:00.000Z
- Updated: 2026-09-14T17:49:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152145

FDA has granted Novartis accelerated approval for Tafinlar (dabrafenib) plus Mekinist (trametinib) for treating patients six years of age and older with unresectable or metastatic solid tumors with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. “The combination of dabrafenib and trametinib demonstrated meaningful efficacy in multiple BRAF-positive tumor types, including in some patients with rare cancers who have no other treatment options available,” a company release says.

Approval was based on data from three clinical trials that showed an overall response rate of up to 80% for the combination therapy in patients with BRAF V600E solid tumors, including high- and low-grade glioma, biliary tract cancer and certain gynecological and gastrointestinal cancers, the company says.

Tafinlar plus Mekinist was previously approved for use in BRAF V600 mutation-positive unresectable or metastatic melanoma, as an adjuvant treatment for BRAF V600 mutation-positive melanoma after surgery, in BRAF V600 mutation-positive metastatic non-small cell lung cancer, and in BRAF V600 mutation-positive anaplastic thyroid cancer, Novartis says.