- The Food and Drug Administration handed another breakthrough designation to Novartis' CAR-T candidate on Tuesday, putting the cancer immunotherapy further on track to compete with Kite Pharma's rival drug.
- CTL019 (tisagenlecleucel) is now breakthrough designated for relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in adults who didn't respond to at least two prior forms of therapy. Previously, the drug had received the tag as a treatment for acute lymphoblastic leukemia.
- Novartis is in a tight race with Kite Pharma to be first to market with a CAR-T therapy. Both companies completed Biologics License Application (BLA) submissions for their respective drugs in late March. Kite's therapy, KTE-019 (axicabtagene ciloleucel), received breakthrough designation for DLBCL in 2015.
In December, the immunotherapy JCAR017 from Juno Therapeutics — the third most advanced CAR-T developer — also snagged breakthrough designation for several cancer indications, including DLBCL. The drug has only completed Phase 1 testing, though, meaning it most likely won't beat competing therapies from Novartis or Kite to market.
With the battle for first place narrowed to two, Novartis and Kite have pursued any tool that could speed up the review of their candidates. Locking down a breakthrough designation forces the FDA to make an approval decision for CTL019 in the DLBCL indication faster than it normally would.
Novartis also has secured a priority review tag for CTL019 in the ALL indication, which typically shaves the FDA's review down to about six months from the standard 10.
If that guidance holds true, Novartis could get a green light from the agency around September.
The decision to classify CTL019 as a breakthrough medication hinged on data from the Phase 2 JULIET trial, a single arm, non-randomized study of 130 DLBCL patients, according to an April 18 statement from Novartis.
The Swiss pharma hasn't disclosed results from JULIET yet, though it intends to at a unspecified future medical meeting. While that lack of available data makes it difficult to assess how the drug stacks up to Kite's treatment, locking down a second designation signals the FDA has at least some faith in its safety and efficacy.
Investors, meanwhile, weren't substantially swayed by the newly minted classification. Novartis shares fell less than 1% to $72.72 apiece by close of market Tuesday. Kite's stock faired a little worse, dropping 3% to $79.63 per share the same day.