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.
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