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Press Release

June 23, 2022
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FDA approves Tafinlar-Mekinist combination for BRAF V600E-mutated solid tumors

Source:

Press Release

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The FDA granted accelerated approval to dabrafenib plus trametinib for treatment of certain patients with unresectable or metastatic solid tumors that harbor BRAF V600E mutations.

The designation applies to use of the combination by patients aged 6 years or older whose disease progressed after prior therapy and who have no satisfactory alternative treatment options.

FDA HQ in Washington

BRAF V600E — which accounts for up to 90% of BRAF-mutant malignancies — drives tumor growth in more than 20 cancer types, including brain, thyroid and gynecologic cancers.

Dabrafenib (Tafinlar, Novartis) is a BRAF inhibitor. Trametinib (Mekinist, Novartis) is a MEK inhibitor. The FDA previously approved the combination for certain patients with BRAF V600 mutation-positive melanoma, non-small cell lung cancer or anaplastic thyroid cancer.

The FDA based the tumor-agnostic indication on results of three clinical trials.

In the phase 2 ROAR basket study and the NCI-MATCH Subprotocol II study, the combination led to overall response rates of up to 80% among patients with BRAF V600E-positive solid tumors. Researchers reported responses among patients with low-grade glioma, biliary tract cancer and certain gastrointestinal or gynecologic cancers.

A third study showed the combination conferred clinical benefit and demonstrated an acceptable safety profile for pediatric patients.

Vivek Subbiah, MD
Vivek Subbiah

“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,” researcher Vivek Subbiah, MD, associate professor of investigational cancer therapeutics and center medical director of Clinical Center for Targeted Therapy at The University of Texas MD Anderson Cancer Center, said in a Novartis-issued press release. “Physicians should consider a BRAF test as a routine diagnostic step that could enable a new option for treating patients with many solid tumors.”

Under terms of FDA’s accelerated approval program, continued approval of the combination for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.