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Kite's Gene Therapy Yescarta Gets Biosimilar Treatment With Second-In-Class Approval

 
• By Michael Cipriano

Much like it did for the first biosimilars, US FDA approved Yescarta without an advisory committee, as Novartis' first-in-class CAR-T cell therapy already set the stage for an agency review.

It appears that Kite Pharma Inc. received the biosimilar treatment from the US FDA in the review and approval of the drugmaker's gene therapy Yescarta (axicabtagene ciloleucel), in that only the first-in-class product received an automatic advisory committee.

FDA approved Yescarta – a CD19-directed genetically modified autologous T cell immunotherapy – Oct. 18 for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, more than one month ahead of its Nov. 29 user fee goal date. Yescarta has become the second agency-approved gene therapy, following FDA's Aug. 30 approval of Novartis AG's CAR-T cell therapy Kymriah (tisagenlecleucel) for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL)

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