Kite’s Yescarta Receives the US FDA’s Approval for R/R Follicular Lymphoma

March 8, 2021 Auto Bot approval, FDA, Follicular Lymphoma, Kite, receives, regulatory, Yescarta 0

Shots:

  • The approval is based on a P-II ZUMA-5 study assessing Yescarta (axicabtagene ciloleucel) in 146 patients aged ≥18rs. with r/r iNHL, prior treated with at least 2L of systemic therapy
  • The P-II ZUMA-5 study showed 91% of patients responded to a single infusion of Yescarta, including ~74% of patients in a continued remission @18mos.; mDoR was not yet reached @median follow-up of 14.5 mos. In the safety analysis, grade 3 or higher CRS and neurologic toxicities occurred in 8% and 21% of patients respectively
  • Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma, follows FDA’s BTD and PR and marks the third approved indication for the therapy

Click here ­to­ read full press release/ article | Ref: Gilead | Image: Businesswire

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