Kite (KITE) Enrolls ZUMA-1 Study, Interim Data, Filing In 2016
Zacks Investment Research | Jul 07, 2016 09:03PM ET
Kite Pharma, Inc. (NASDAQ:KITE) announced that it has finished enrolling patients in the diffuse large B-cell lymphoma (DLBCL) cohort of the phase II portion of the ZUMA-1 study on KTE-C19.
The company expects to report top-line data from the first 50 DLBCL patients in the ZUMA-1 study and also file for FDA approval, provided the results support the same, by year end. If all goes well, KTE-C19 could be launched as early as 2017. The company intends to file for EU approval in 2017.
KTE-C19, an anti-CD19 CAR-based therapy, is currently in three other pivotal studies as well. These include ZUMA-2 in patients with relapsed/refractory mantle cell lymphoma (MCL), ZUMA-3 for adult acute lymphoblastic leukemia (ALL) and ZUMA-4 for pediatric ALL, with results from all these studies due in 2017.
KTE-C19 has orphan drug status in the U.S. and EU for all the hematological indications being evaluated by the company - primary mediastinal B cell lymphoma (PMBCL), MCL, follicular lymphoma (FL), ALL, chronic lymphocytic leukemia (CLL) and DLBCL.
Moreover, last month, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) granted access to its newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory DLBCL. This status is granted to support the development and speed up the review of new therapies to treat patients with unmet medical need.
In the U.S., KTE-C19 has Breakthrough Therapy Designation for the treatment of patients with DLBCL, PMBCL, and transformed follicular lymphoma (TFL).
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