Swiss pharma firm Novartis announced last week the Biologics License Application (BLA) filing for CTL019 (tisagenlecleucel-T) – its investigational CAR-T therapy for patients with B-cell acute lymphoblastic leukemia (ALL) – has been accepted by the US Food and Drug Administration (FDA).
The product is made using cells drawn from an individual patient which are then reprogrammed to create genetically coded T cells. These are reintroduced to the patient where they ‘hunt’ cancer cells and other B-cells expressing a particular antigen.
CTL019 has also been granted priority review by the regulatory agency which potentially shortens the window for the FDA to take action on the product.
Meanwhile, California-headquartered biotech Kite Pharma has completed the rolling submission with the FDA of the BLA for its CAR T-Cell candidate, axicabtagene ciloleucel (previously known as KTE-C19).
“We look forward to working closely with the FDA during the review of axicabtagene ciloleucel and the possibility of bringing this therapy to patients with aggressive NHL whose outlook is dismal with current therapy,” Kite CEO Arie Belldegrun said.
The autologous therapy – which received Breakthrough Therapy Designation in December 2015 – could launch later this year if given the FDA approval, according to Kite.
The two companies are not alone in looking to bring a CAR T-cell therapy to market.
According to a presentation at a European Medicines Agency (EMA) workshop on cancer immunotherapies by David Lebwohl, Novartis’ VP of CAR T, there are nine such therapies – autologous and allogeneic – in the clinic: