CAR T therapy commercialization took another step forward this past week as both Kite Pharma and Novartis completed filings to the Food and Drug Administration for their respective treatments, setting the stage for potential approvals to come ideally later this year. The Novartis CAR T product for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia is based on work by Dr. Carl June, University of Pennsylvania, partially funded by ACGT. Kite is seeking approval for its CAR T drug in patients with relapsed/refractory aggressive Non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant. CAR Ts are the next generation of cancer immunotherapies and involve taking a patient’s own T cells through a blood draw, and genetically modifying them in a lab to bind to antigens present on cancer cells.
With these filings, the question will be which company is first to market with its CAR T therapy. The first company to do so will be able to set pricing for the treatments and both hope to launch before year-end. According to analyst projections, sales for Kite are forecast to approach $7.9 billion in 2002, while Novartis’ rival CAR T is expected to produce sales in the area of $4.7 billion.