CAR-T, Results

Novartis hustles along another FDA application for CAR-T star, tackling Gilead head on

Gilead likely won’t have DLBCL cancer to itself in the CAR-T arena for very long.

Novartis put out word early Tuesday that it has added positive 6-month data to its package on its CAR-T Kymriah  (tisagenlecleucel) and sent it in to the FDA for their review on diffuse large B-cell lymphoma.

We don’t know what the 6-month data look like, but the pharma giant says it will tell all at the upcoming ASH conference in Atlanta in early December. Researchers have, however, spelled out a success after three months, just as Kite has.

Vas Narasimhan

The move comes just days after Gilead’s newly acquired $12 billion subsidiary Kite won their first OK for the same indication. Novartis got started with an approval for acute lymphoblastic leukemia and plans to expand the blockbuster franchise as rapidly as possible. And before the end of this year Novartis’ CAR-T team plans to follow up with European applications for both.

They are likely to get a lot of help from regulators.

The FDA’s cancer division has established a rep in the industry as a fast mover when it comes to accelerated reviews. Kymriah is one of their “breakthrough” drugs, which commits the agency to speedy action on their behalf. And once regulators get some experience with the first approval, these new meds can stack up approvals at a rapid pace.

None of that, though, should mean that Gilead can’t compete on its own. The big biotech has a fearsome rep in the commercial market, and a track record for capitalizing on success. In this arena, it’s also likely to hit hard on a better turnaround time in making these personalized cell therapies, looking to build a reputation for better quality over Novartis, which has had some issues on the manufacturing side of the business to contend with.

Pricing may also get a second look. Novartis started out pricing Kymriah at $475,000, but only when a patient responds to therapy. Gilead started out at $373,000 for Yescarta, with no qualification on response.

Novartis development chief — and soon CEO — Vas Narasimhan isn’t shy about touting Kymriah’s potential.

The response rates we’ve seen in the JULIET trial show that Kymriah has the potential to transform treatment for these patients and we look forward to collaborating with the FDA to make it available to patients for this second indication.



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