Gene Tx Approved for Certain Types of B-Cell Lymphoma
THURSDAY, Oct. 19, 2017 --Yescarta (axicabtagene ciloleucel) has been approved by the U.S. Food and Drug Administration for individuals with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment.
Yescarta is a chimeric antigen receptor T cell therapy. The treatment is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).
Yescarta is approved for adults for whom at least two other types of treatment have failed for NHL such as diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. The therapy was evaluated in a multicenter clinical trial involving more than 100 adults, where the complete remission rate after treatment with Yescarta was 51 percent, the FDA said.
The therapy includes a boxed warning for cytokine release syndrome and neurologic toxicities, the FDA said. Patients must be informed of these risks before receiving the therapy. Other potential side effects include serious infections, low blood-cell counts, and a weakened immune system. Hospitals that provide the therapy will have to be specially certified, the FDA said.
The therapy is produced by Los Angeles-based Kite Pharma Inc., which as a condition of approval must conduct studies of the therapy's long-term effects, the agency said.
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Posted: October 2017