Novartis announced Thursday that the US Food and Drug Administration (FDA) has granted accelerated approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation. According to the company, it will focus on the tumors that have progressed after previous treatment and lack satisfactory alternative treatment options.
According to the company’s press release, Tafinlar + Mekinist is the first and only BRAF/MEK inhibitor approved with a tumor-agnostic indication for solid tumors carrying the BRAF V600E mutation, which stimulates tumor growth in more than 20 different tumor types. In addition, it is the only BRAF/MEK inhibitor approved for use in pediatric patients.
“The combination of dabrafenib and trametinib has demonstrated meaningful efficacy in multiple BRAF-positive tumor types, including in some patients with rare cancers who have no other treatment options. Physicians should consider a BRAF test as a routine diagnostic step that could provide a new option for treating patients with many solid tumors,” lead researcher Dr. Vivek Subbiah, MD, associate professor of Investigational Cancer Therapeutics and medical center director of the Clinical Center for Targeted Therapy, Division of Cancer Medicine, at the University of Texas MD Anderson Cancer Center in Houston, Texas in a statement.
Meanwhile, the FDA approval was based on clinical efficacy and safety demonstrated in three clinical studies.
“In the Phase II ROAR (Rare Oncology Agnostic Research) basket trial and the NCI-MATCH Subprotocol H trial, Tafinlar + Mekinist resulted in overall response rates of up to 80% in patients with BRAF V600E solid tumors, including high- and low-grade glioma, bile duct cancer and certain gynecological and gastrointestinal cancers. An additional study (Study X2101) demonstrated the clinical benefit and acceptable safety profile of Tafinlar + Mekinist in pediatric patients,” it said.
“Tackling cancer is complex, which is why it is so important that we continue to follow science as we pursue meaningful progress and new approaches to cancer treatment. We are grateful to the patients and the many individuals and teams working together to make this latest approval possible. as we strive to do more for more people with cancer,” Reshema Kemps-Polanco, head, Novartis Oncology US said in a statement.
The safety profile of Tafinlar + Mekinist observed in these studies was consistent with the known safety profile in other approved indications, the company claims.
According to experts, BRAF mutations have been identified as drivers of cancer growth in a wide range of solid tumors, including rare cancer types that can be challenging to study in phase III trials and often have limited treatment options. BRAF V600E is the most common type of BRAF mutation, accounting for up to 90 percent of BRAF-mutated cancers, they said.
