FDA Approves Yescarta, Agency's Second CAR-T Gene Therapy Approval

FDA approved Wednesday (Oct. 18) Kite Pharma's Yescarta (axicabtagene ciloleucel), marking the second gene therapy approved in the United States and the first for certain types of non-Hodgkin lymphoma. The treatment will cost nearly $375,000, which is $100,000 less than the first FDA-approved CAR-T treatment. Commissioner Scott Gottlieb announced alongside the approval that FDA will soon issue a comprehensive agency policy clarifying how FDA's expedited programs apply to gene therapy products. FDA made waves when it announced earlier this year...