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The FDA has to the BRAF inhibitor dabrafenib (Tafinlar) combined with the MEK inhibitor trametinib (Mekinist) for the treatment of adults and children with unresectable or metastatic solid tumors with a BRAF V600E mutation, who have progressed following prior treatment and have no adequate alternative treatment options, Novartis announced.

The combination is the first and only therapy to be approved with a tumor-agnostic indication for solid tumors with a BRAF V600E mutation, the company said, as well as the only BRAF/MEK inhibitor approved for use in pediatric patients.

"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," said Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center in Houston, in a statement. "Physicians should consider a BRAF test as a routine diagnostic step that could enable a new option for treating patients with many solid tumors."

Dabrafenib plus trametinib is also approved for use in melanoma, non-small cell lung cancer, and anaplastic thyroid cancer with BRAF V600 mutations. The combination is not indicated for patients with colorectal cancer or patients with wild-type BRAF solid tumors.

The new approval was based on clinical efficacy and safety demonstrated in three clinical trials.

Results from the phase II ROAR and NCI-MATCH studies demonstrated overall response rates of up to 80% in patients with BRAF V600E solid tumors, including high- and low-grade gliomas, biliary tract cancer, and certain gynecologic and gastrointestinal cancers, while Study X2101 demonstrated clinical benefit and an acceptable safety profile in pediatric patients.

The observed safety profile of the BRAF/MEK inhibitor was consistent with what has been seen for other approved indications.

The combination may help to slow tumor growth by blocking signals associated with the BRAF and MEK kinases that are implicated in the growth of multiple types of cancers, including rare cancers.

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