Kite Pharma Cancer Drug BLA Gets Priority Review Status
Zacks Investment Research | May 29, 2017 08:23AM ET
Kite Pharma, Inc. (NASDAQ:KITE) announced that its biologics license application (BLA) for its experimental CAR-T therapy, axicabtagene ciloleucel has been accepted for priority review by the FDA.
The biotech companyis looking to get axicabtagene ciloleucel approved for the treatment of aggressive non-Hodgkin lymphoma (NHL).
With the FDA granting priority review, a decision should be out on Nov 29, 2017.
The acceptance of the BLA on a priority review basis is based on positive data from primary analysis of the ZUMA-1 phase II study. The data showed that a single infusion of axicabtagene ciloleucel demonstrated a significant efficacy with an 82% ORR and a 39% ongoing complete response rate and favorable safety profile.
The company is evaluating axicabtagene ciloleucel, an experimental anti-CD19 chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of various types of aggressive non-Hodgkin’s lymphoma (NHL) including diffuse large B cell lymphoma (DLBCL) primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL).
A look at Kite Pharma’s share price movement over the past one year shows that the stock has significantly outperformed the Zacks classified Original post
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