FDA Gives Approval For Novartis' Tafinlar + Mekinist Broadens BRAF/MEK Cancer Combo Use

The FDA granted accelerated approval to Novartis AG's NVS pairing of Tafinlar and Mekinist for any advanced solid tumors with the BRAF V600E mutation.
The patient must have progressed following prior therapy and have no alternative treatment options.
The combo is already approved for BRAF mutated non-small cell lung cancer, melanoma, and thyroid cancer.
Individuals as young as six years will be eligible to take the drug, making it the first BRAF/MEK inhibitor approved in pediatrics, Novartis said.
Also Read: New Data Shows Novartis' Kisqali Extends Survival In Postmenopausal Breast Cancer Setting.
The FDA approval was based on clinical efficacy and safety demonstrated in three clinical trials, including a basket cancer trial that saw overall response rates reach as high as 80% in some tumors.
Novartis tested the combo in tumors such as gliomas, biliary tract cancer, and gynecological and gastrointestinal cancers.
Novartis said that the approval would likely give the use of the drug in over 20 different types of tumors.
Price Action: NVS shares are down 0.10% at $81.59 during the market session on the last check Thursday.