Results from the Novartis (NVS) cell therapy cancer clinical trial known as JULIET remain out of sight to investors -- and its close competitor Kite Pharma (KITE) -- but the Swiss pharma giant did snag a Breakthrough Therapy Designation from the FDA after sharing the trial data with regulators.
The new FDA "breakthrough" tag for Novartis' genetically altered cell therapy CTL019 announced Tuesday is based on the JULIET study that enrolled patients with diffuse large B-cell lymphoma (DLBCL) whose disease has returned or is unresponsive to prior treatments.
The data to emerge from Novartis' JULIET study is of keen interest to investors because it will be compared against Kite Pharma's competing "CAR-T" KTE-C19 in the same DLBCL patients.
The FDA appears to like Novartis' JULIET data well enough to drop a breakthrough label on CTL019 but how the therapy stacks up against Kite's KTE-C19 is not known quite yet.
On Tuesday, Novartis reiterated its pledge to present the JULIET study results at a medical meeting without offering specifics.
Both Novartis and Kite have already submitted their respective CAR-T therapies to the FDA but the initial approval requests are for different types of blood cancer patients. Novartis' marketing package for CTL019 covers children with acute lymphoblastic leukemia (ALL.) Kite is going for approval of KTE-C19, also known as axi-cel, in DLBCL.
But Novartis is trying to move fast to expand use of CTL019 into DLBCL, setting up a more direct competitive battle against Kite. And that's why the JULIET study results, now bolstered with the imprimatur of breakthrough therapy status, are so important.
FDA previously granted "breakthrough" status to KTE-C19 in DLBCL, so on that score, Kite and Novartis are even.