Product Promotion Network

The FDA priority review gives Kite’s CAR-T a PDUFA date of November 29

Kite Pharma has secured[1] a priority review at the FDA for its CAR-T candidate. The shaving of four months off the review time tees Kite up to secure approval by the end of November, two months after Novartis is expected to get the all clear to start selling its rival CAR-T therapy. Securing a priority review for KTE-C19, also known as axicabtagene ciloleucel, means Kite will wait six months rather than the typical 10 months to learn whether the FDA will grant it approval.

The PDUFA date is set for November 29. Novartis made no mention of its PDUFA date when it revealed the FDA had given priority review status to its CAR-T, CTL019. But given Novartis disclosed the news on March 29 and FDA priority reviews take up to six months, the PDUFA date is likely to fall around late September.

That would put Novartis two months closer to market than Kite. The rivals are targeting different indications for their first approvals. Kite’s application and priority review covers the use of KTE-C19 in non-Hodgkin lymphoma (NHL).

Novartis is seeking approval for CTL019, also known as tisagenlecleucel-T, in kids and young adults with B-cell acute lymphoblastic leukemia (ALL). While the pursuit of different initial indications means Kite and Novartis are currently racing on parallel tracks, the overlap in their technologies and future plans mean more direct collisions are coming. KTE-C19 and CTL019 are both weaponized versions of each patient’s own cells.

And Kite and Novartis are pursuing some of the same indications for future approvals. Both companies have FDA breakthrough tags in DLBCL, a type of NHL that afflicted most of the patients Kite enrolled in its pivotal trial. Novartis secured its breakthrough status on the strength of data from its Juliet study.

The wider world is due to get its first look at the data–and assess how they compare to Kite’s results–at a conference in Switzerland on June 14.

Those data, the extent to which KTE-C19 and CTL019 avoid the safety problems that held back Juno Therapeutics and the ability of Kite and Novartis to manage the logistical and commercial challenges of autologous products will go a long way to dictating how the companies’ CAR-T therapies fare.



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