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Novartis Scores Its First Tumor-Agnostic Label For Two Nearly Decade-Old Cancer Drugs

 
• By Alaric DeArment

The FDA approved Tafinlar/Mekinist for BRAF V600E-mutated solid tumors, based in part on a Phase II basket trial studying more than two dozen drugs across dozens of cancers based on genetic testing.

Novartis is the latest company to win FDA approval in a tumor-agnostic cancer indication • Source: Shutterstock

Novartis AG has become the latest company to win US Food and Drug Administration approval for a tumor-agnostic cancer indication, in this case for the BRAF inhibitor Tafinlar (dabrafenib) and the MEK inhibitor Mekinist (trametinib), for solid tumors carrying BRAF V600E mutations. The two-drug combination is the first to win approval in that indication but joins a list of drugs that have secured biomarker-driven, tissue-agnostic labels since 2017, which reflects the growing view of cancers as genomic diseases.

Novartis said 22 June that the FDA granted accelerated approval to Tafinlar/Mekinist in children and adults aged 6 and older...

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