2023-03-17 05:45:02 ET
The U.S. Food and Drug Administration (FDA) approved the expanded use of Novartis' ( NYSE: NVS ) Tafinlar plus Mekinist to treat children one year of age and older with low-grade glioma (LGG) having a BRAF V600E mutation, requiring systemic therapy.
Glioma is type of tumor/cancer which starts in the brain or spinal cord.
The Swiss pharma giant said the FDA also approved liquid formulations of Tafinlar (dabrafenib) and Mekinist (trametinib), marking the first time a BRAF/MEK inhibitor has been developed in a formulation suitable for patients as young as one year old.
Novartis noted that this was sixth FDA approval for Tafinlar + Mekinist, which is used across multiple BRAF V600 solid tumors, including melanoma, thyroid cancer and lung cancer.
The approval for the liquid formulation options would help with the ease of administration across multiple approved indications, the company added.
The current FDA approval was backed by data data from a phase 2/3 trial called TADPOLE.
"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," said Reshema Kemps-Polanco, executive vice president, US Oncology at Novartis.
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Novartis Tafinlar Mekinist combo gets FDA approval to treat brain cancer in children