Kite Pharma, Inc.
We note that PRIME is a new initiative undertaken by the EMA to provide better scientific guidance and support accelerated review of investigational therapies that address a high unmet medical need. The initiative also offers early and enhanced regulatory support to optimize regulatory applications.
Consequently, Kite Pharma will now work closely with the CHMP and CAT as it progresses with the multi-center ZUMA studies on KTE-C19, and moves ahead with the marketing authorisation application process.
The candidate was also granted Breakthrough Therapy designation for the treatment of patients with DLBCL, primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma by the FDA in Dec 2015. Moreover, KTE-C19 enjoys orphan drug status in the U.S. and the EU for DLBCL, PMBCL, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia.
The news bodes well for Kite Pharma as it should accelerate the development and consequent review of the candidate. We note that Kite Pharma has no marketed products in its portfolio yet.
In addition, Biogen Inc.
Kite Pharma and Biogen currently carry a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Pfizer Inc.
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