Pharma Focus Asia

Novartis Tafinlar + Mekinist Approved by FDA for Paediatric Patients

Friday, March 17, 2023

Novartis announced the U.S. Food and Drug Administration (FDA) granted approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of paediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved liquid formulations of Tafinlar and Mekinist, marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year of age. These approvals make Tafinlar + Mekinist the first and only approved combination targeted therapy to treat paediatric patients with BRAF V600E LGG.

Tafinlar + Mekinist is now approved in six indications across multiple BRAF V600E solid tumours, including melanoma, thyroid cancer and lung cancer. This new indication for Tafinlar + Mekinist is a potential new standard of care treatment option for young patients with this form of brain cancer with a BRAF V600E mutation, in formulations specifically designed for them.

The combination of Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition research and patients reached, help to slow tumour growth by blocking signals associated with the BRAF and MEK kinases that are implicated in the growth of various types of cancer.

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