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

• The FDA granted accelerated approval to Novartis AG's (NYSE: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.