By Joshua Kirby

 

Novartis AG said Thursday that its cancer-treatment drug combination, Tafinlar + Mekinist, has been granted accelerated approval by the Food & Drug Administration after successful clinical trials.

Tafinlar (dabrafenib) + Mekinist (trametinib) can now be used in adult and pediatric patients above 6 years of age for the treatment of unresectable or metastatic solid tumors with BRAF V600E mutation that have no satisfactory alternative treatment options, the Swiss drugmaker said.

Under the FDA's accelerated approval program, further approval might depend on confirmatory trials, Novartis said.

The decision comes after three clinical trials that showed good overall response rates and a consistent safety profile, the company said.

 

Write to Joshua Kirby at joshua.kirby@wsj.com; @joshualeokirby

 

(END) Dow Jones Newswires

June 23, 2022 01:31 ET (05:31 GMT)

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