Kite Pharma, Inc. 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 Medical - Biomedical and Genetics industry. Specifically, Kite’s stock gained 53.1% during this period, while the industry lost 12%.
However, we remind investors that earlier this month, shares of the company had declined sharply after it announced the death of a cancer patient in a safety expansion cohort to the ZUMA-1 study. Kite Pharma had said that the patient was very sick and died of multi-organ failure and cerebral edema in late April. Cerebral edema was the same adverse event for which Juno Therapeutics, Inc.’s phase II study (ROCKET) on its most advanced pipeline candidate, JCAR015, for relapsed/refractory acute lymphoblastic leukemia (r/r ALL) was placed on clinical hold. The investor community was expecting the candidate to be nevertheless approved based on the efficacy and safety profile of axicabtagene ciloleucel seen to date.
With the FDA granting priority review to the candidate, it once again looks likely to be approved this year.
We note that Kite Pharma is also evaluating axicabtagene ciloleucel in another phase II study (ZUMA-2) in patients with relapsed/refractory mantle cell lymphoma (MCL) and in two additional pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL) – ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL. Kite Pharma plans to move axicabtagene ciloleucel into a second series of studies for additional indications and earlier lines of therapy in DLBCL patients in 2017. A phase Ib/II combination study (ZUMA-6) evaluating axicabtagene ciloleucel plus Roche Holding AG’s (RHHBY - Free Report) subsidiary, Genentech’s Tecentriq (atezolizumab) in patients with chemorefractory DLBCL commenced in Oct 2016.
We remind investors that Novartis A.G. (NVS - Free Report) has also received priority review status in Mar 2017 for its BLA for its CAR-T candidate, CTL019 for the treatment of relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
Kire Pharma currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.
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