Zurich (AFP) – The FDA, the US drug authority, has granted accelerated approval to the combination of the drugs Tafinlar (dabrafenib) and Mekinist (trametinib) against certain forms of cancer, Novartis said in a press release on Thursday. The treatment is intended for adults and children over six years of age.
The combination is intended for patients with unresectable or metastatic solid tumors with BRAF V600E mutation, which have progressed after previous treatment and who have no other satisfactory treatment options. The mutation in question leads to the growth of more than 20 different tumor types, Novartis says.
In accordance with the accelerated approval program, the maintenance of approval for this indication may be subject to verification and description of the clinical benefit in one or more confirmatory trials, further specifies the Basel laboratory.
The combination of the two molecules has proven to be very effective in several types of tumors, including in certain patients with rare cancers for which no other treatment option is available, the press release continues. FDA clearance is based on data from three clinical studies.
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