The FDA granted priority review to the investigational chimeric antigen receptor T-cell therapy KTE-X19 for the treatment of adults with relapsed or refractory mantle cell lymphoma.
KTE-X19 (Kite, Gilead) is an anti-CD19 autologous CAR T-cell therapy that targets the CD19 protein when it is expressed on the surface of cancer cells. Approval of KTE-X19 would make Kite the first manufacturer with more than one FDA-approved CAR T-cell therapy.
“Despite recent advances, patients with relapsed or refractory mantle cell lymphoma currently face a significant lack of effective treatment options once their disease no longer responds to currently available therapy,” Ken Takeshita, MD, global head of clinical development at Kite, said in a company-issued press release. “Based on the encouraging results for KTE-X19, we are eager to continue discussions with the FDA on how to bring this innovative treatment to these patients who may benefit from CAR T[-cell] therapy.”
The FDA accepted Kite’s biologics license application (BLA) for KTE-X19 for this indication in December, as Healio previously reported.
Kite supported the BLA with phase 2 data from the multicenter ZUMA-2 trial presented at last year’s ASH Annual Meeting and Exposition. The results showed an overall response rate of 93% and a complete response rate of 67%. Researchers observed grade 3 or higher cytokine release syndrome and neurotoxicity among 15% and 31% of patients, respectively. No patients experienced grade 5 cases of these toxicities.
The FDA set a target action date of Aug. 10.
KTE-X19 is being tested in clinical trials for additional indications that include adult acute lymphoblastic leukemia (ZUMA-3), pediatric ALL (ZUMA-4) and chronic lymphocytic leukemia (ZUMA-8).