Novartis Announces FDA Accelerated Approval of Tafinlar (dabrafenib) and Mekinist (trametinib) Combination for BRAF V600E Solid Tumors Across All Ages

Novartis announced today that the U.S. FDA has granted accelerated approval for its Tafinlar (dabrafenib) / Mekinist (trametinib) combination therapy to treat adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors harboring the BRAF V600E mutation. These patients have experienced disease progression following prior therapies and have no satisfactory alternative treatment options. The press release noted that Tafinlar + Mekinist is the first approved BRAF/MEK inhibitor for the treatment of BRAF V600E solid tumors regardless of cancer type. This mutation drives tumor growth in more than 20 different types of cancer. It is also the first time a BRAF/MEK inhibitor has been approved for use in pediatric patients.

FDA Approval Based on Safety and Clinical Efficacy Results from Three Clinical TrialsIn the ROAR basket phase 2 clinical trial and the NCI-MATCH subprotocol H study, Tafinlar + Mekinist achieved an overall response rate of up to 80% in patients with solid tumors carrying the BRAF V600E mutation. Patients included those with high-grade and low-grade gliomas, biliary tract cancer, as well as certain gynecological and gastrointestinal cancers. Another study showed that Tafinlar + Mekinist demonstrated clinical benefit and an acceptable safety profile in pediatric patients.

Tafinlar+Mekinist delay tumor growth by inhibiting the activity of the BRAF and MEK protein kinases. They have been studied in more than 20 clinical trials involving over 6,000 BRAF-positive patients.

"Dabrafenib and trametinib combination shows meaningful efficacy in various BRAF-positive tumor types, including some rare cancer patients without other treatment options," said Dr. Vivek Subbiah, the principal investigator of the clinical trial from MD Anderson Cancer Center. "Doctors should consider BRAF testing as part of routine diagnosis, which may offer this new treatment option to many patients with solid tumors."

References:

[1] Novartis Tafinlar + Mekinist receives FDA approval for first tumor-agnostic indication for BRAF V600E solid tumors. Retrieved June 22, 2022, from https://www.globenewswire.com/news-release/2022/06/22/2467557/0/en/Novartis-Tafinlar-Mekinist-receives-FDA-approval-for-first-tumor-agnostic-indication-for-BRAF-V600E-solid-tumors.html

Original Title: Regardless of Cancer Type! Novartis Precision Therapy Combination Receives FDA Accelerated Approval

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