Novartis, Kite Pharma Plan Regulatory Filings for CAR T Therapies

Novartis and Kite Pharma, a Santa Monica, California-based clinical-stage biopharmaceutical company, have both announced plans for filing applications seeking regulatory approval for their respective chimeric antigen receptor T-cell (CAR T) therapies to treat cancers. Novartis plans to file its CAR T therapy, CTL019, with the US Food and Drug Administration (FDA) in early 2017 while Kite has initiated a rolling submission with the FDA of a biologics license application (BLA) for its lead CAR T therapy candidate, axicabtagene ciloleucel (formerly KTE-C19).

CAR T therapies involve taking a person’s own T cells (immune cells) and genetically reprogramming them to hunt and potentially kill cancer cells.

Novartis will be submitting an application for CTL019 for treating relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). In addition to filing CTL019 for approval with the FDA in early 2017, Novartis plans to file with the European Medicines Agency later in 2017. The therapy received priority medicines (PRIME) designation from the EMA earlier this year.

Earlier this year in September 2016, Novartis reintegrated its CAR T technology development with its main organization after disbanding its cell and gene therapies unit, of which the CAR T operations were a part. Novartis said that the reintegration would not impact the company’s regulatory filing plans for CTL019.

In addition, Novartis continues its collaboration, formed in August 2012, with the University of Pennsylvania (Penn) for CAR T therapy development. In February 2016, Novartis and Penn unveiled a center for advanced cellular therapeutics on the Penn campus, which was constructed in part through a $20-million investment from Novartis.

Similarly, Kite is moving forward with its CAR T therapy program, seeking a cancer treatment indication with its BLA submission. The company is seeking approval for axicabtagene ciloleucel as a treatment for patients with r/r aggressive B-cell non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant. Kite expects to complete its BLA submission by the end of the first quarter of 2017.

Axicabtagene ciloleucel received breakthrough therapy designation from the FDA in December 2015. If approved, Kite plans to commercially launch the therapy in 2017. Kite is also planning a regulatory submission to the EMA for axicabtagene ciloleucel in 2017. Kite was granted access to PRIME regulatory support in 2016 by the EMA for axicabtagene ciloleucel in treating refractory diffuse large B-cell lymphoma.

In June 2016, Kite opened a new 43,500-square-foot, commercial manufacturing facility in El Segundo, California for producing CAR and T-cell receptor product candidates for clinical trials. The new facility will also be used for the potential launch and commercialization of axicabtagene ciloleucel.

Source: Novartis and Kite Pharma

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