Kite Pharma, Inc. KITE announced that its immuno-oncology candidate, KTE-C19, has been granted access to the Priority Medicines (PRIME) regulatory initiative in Europe by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) for the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL).
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. BIIB announced that its pipeline candidate, aducanumab, was accepted for the PRIME program for early Alzheimer’s disease (AD) primarily based on positive results from the phase Ib placebo-controlled study on aducanumab in patients with prodromal or mild AD. Meanwhile, Biogen is evaluating aducanumab in two global phase III studies – ENGAGE and EMERGE – to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in patients suffering from AD.
Kite Pharma and Biogen currently carry a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Pfizer Inc. PFE and Bristol-Myers Squibb Co. BMY, both sporting a Zacks Rank #1 (Strong Buy).
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