Novartis Tumor Treatment Gets US Nod
23 Junho 2022 - 2:46AM
Dow Jones News
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)
Copyright (c) 2022 Dow Jones & Company, Inc.
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