FDA Approves Tafinlar Plus Mekinist for Patients With BRAF V600-Mutant Solid Cancers


Tafinlar plus Mekinist is now approved by the Food and Drug Administration to treat adults and children over the age of 6 who have BRAF V600-mutant advanced solid cancers.

The Food and Drug Administration (FDA) approved Tafinlar (dabrafenib) plus Mekinist (trametinib) for the treatment of patients over the age of 6 with unresectable or metastatic solid tumors that harbor a BRAF V600E mutation who experienced disease progression and have no other satisfactory treatment options, according to Novartis, the pharmaceutical company developing both of the drugs.

“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 principal investigator Dr. Vivek Subbiah, an associate professor of investigational cancer therapeutics and center medical director of the Clinical Center for Targeted Therapy, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston, in a press release.

The drug duo, which inhibits the BRAF/MEK gene mutations that are associated with cancer growth, was approved based on findings from the phase 2 ROAR (Rare Oncology Agnostic Research) and NCI-MATCH Subprotocol H studies. Findings from the research showed that 80% of patients responded (had their tumors shrink) as a result of Tafinlar plus Mekinist treatment.

Cancer types that were studied include high- and low-grade glioma, biliary tract cancer and some gynecologic and gastrointestinal cancers. All patients had mutations in the BRAF V600 gene, which makes up about 90% of all BRAF mutations.

“Physicians should consider a BRAF test as a routine diagnostic step that could enable a new option for treating patients with many solid tumors,” Subbiah said.

Another clinical trial, Study X2101, also demonstrated the efficacy and acceptable side effect profile for the drug duo, which was consistent with the safety profile observed in prior studies of Tafinlar plus Mekinist.

“Tackling cancer is complex, which is why it is so important that we continue to follow the science as we pursue meaningful advances and new approaches to treating cancer,” said Reshema Kemps-Polanco, head of Novartis Oncology US, in the release.

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