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Will Kite (KITE) Get Orphan Status Again in EU for KTE-C19?

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Kite Pharma, Inc.KITE looks set to gain orphan drug status in the EU for two additional indications for its lead pipeline candidate, KTE-C19. The company said that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion regarding the granting of orphan drug status to KTE-C19 for the treatment of primary mediastinal B-cell lymphoma (PMBCL) and mantle cell lymphoma (MCL).

KTE-C19 already has orphan drug designation in the EU as well as the U.S. for the treatment of diffuse large B-cell lymphoma (DLBCL).

Orphan drug status in the EU is granted to treatments for life-threatening or chronically debilitating conditions affecting no more than five in 10,000 people in the EU, and for which no satisfactory treatment is available.

Apart from providing companies with regulatory and financial incentives, orphan drug status in the EU comes with a 10-year period of marketing exclusivity after approval.

KTE-C19, a CAR-based therapy, is currently in a phase I/II study in patients with refractory, aggressive non-Hodgkin's lymphoma, including DLBCL and PMBCL, with initial topline results from the phase I part of the study expected later this year. Compelling data from this study could result in the company seeking accelerated FDA approval for these indications. Meanwhile, plans are on to start phase II studies in patients with relapsed/refractory MCL, chronic lymphocytic leukemia and acute lymphoblastic leukemia.

Kite is looking to revolutionize cancer treatments by engaging the body's own immune system to treat cancer. The company has collaboration agreements with Amgen AMGN and bluebird bio, Inc. BLUE .

Kite is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the health care sector is Gilead Sciences, Inc. GILD . Gilead is a Zacks Rank #1 (Strong Buy) stock.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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