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Kite Pharma Completes Filing for CAR-T Therapy with FDA

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Kite Pharma, Inc. KITE announced that it has completed the filing of a rolling submission of the Biologics License Application (BLA) for its lead pipeline candidate, axicabtagene ciloleucel to the FDA.

We note that axicabtagene ciloleucel is Kite Pharma’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy.

The BLA is for the treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT).

So far this year, Kite Pharma’s shares are up 74.7%. This compares favorably with the 3.6% increase registered by the Zacks classified Biomed/Genetics industry during this period.

Kite Pharma is looking to get axicabtagene ciloleucel approved for a broader label of aggressive NHL including drefractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) indications, based on the primary analysis of ZUMA-1 study. DLBCL, TFL and PMBCL are all types of aggressive NHL.

Last month, Kite Pharma announced positive top-line six-month results from the primary analysis of 101 patients in the ZUMA-1 study. The study met the primary endpoint. At the end of six months, after axicabtagene ciloleucel treatment, 41% of the patients achieved a response, including 36% achieving a complete response. The key takeaway from the data was the durability of response compared to data presented for the third month. The solid efficacy profile demonstrated by the study furthers the likelihood of FDA approval of the drug. In Sep 2016, the company had announced encouraging top-line results from the phase II part of ZUMA-1 study.

Axicabtagene ciloleucel is expected to be approved and launched in 2017. In Europe, regulatory applications are expected to be filed in the second half of this year.

We note that the development of CAR T cell therapies has been attracting a lot of attention lately with several companies eyeing this field. Juno Therapeutics Inc. JUNO is also working on developing therapies utilizing the CAR T cell technology. In fact, interest in immunotherapy is building up fast. The basic concept of cancer immunotherapy or immuno-oncology is to utilize certain parts of the immune system to fight the disease. This can be done by stimulating the immune system to attack cancer cells or by introducing immune system components into the body.

Merck & Co., Inc.’s MRK anti-PD-1 therapy, Keytruda, is being studied for more than 30 types of cancers. Amgen Inc.’s AMGN Blincyto, a BiTE antibody, gained earlier-than-expected FDA approval in Dec 2014. Blincyto has the potential to be developed for other hematologic malignancies as well.

Kite Pharma carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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