The biotech announced this morning that the FDA is providing a priority review for their drug KTE-C19 (axicabtagene ciloleucel), which will cut the time it takes for regulators to complete their examination from 10 months down to 6. The FDA’s PDUFA date is November 29.
Kite’s big rival Novartis won a priority review two months ago, which should provide a comfortable lead for the first decision on its landmark drug. Both represent the cutting edge of a new class of drug that extracts cells from patients and then reengineers them into an attack weapon targeting cancer cells.
Both KTE-C19 and Novartis’ CTL019 are tapped as two of the top blockbusters in the industry pipeline. They’re going after different indications on the first round, with Kite initially taking on drug-resistant non-Hodgkin lymphoma. But Novartis — taking its first shot at children with acute lymphoblastic leukemia — will switch focus to its JULIET study for some head-to-head comparisons on diffuse large B-cell lymphoma that will attract plenty of intense attention, as well as speculation over the impact it will have on Kite’s stock price.
That new data — which already earned a special breakthrough title at the FDA — should arrive next month.
In the meantime, regulators will be following through on reviews for two designated ‘breakthrough’ drugs, making it at least possible for the two drugs to reach an expert panel at about the same time.
Kite had managed to get through its registration program without any exceptional safety issues — right until it was hit a few weeks ago with the death of a patient due to cerebral edema. The biotech went to some pains to note just how sick this patient was when he died, but its stock slid as investors considered the implications. Juno’s lead CAR-T was knocked out of the race when 5 patients died of cerebral edemas, or brain swelling, including 2 who died after the FDA decided to lift a clinical hold on the program after just a few days.
Those deaths and all the safety issues facing CAR-T therapies will now get careful scrutiny at the FDA.
“Patients with refractory aggressive NHL face a dire prognosis with only a 50 percent chance of surviving six months. This underscores the urgent medical need for these patients and why every day matters, from development to manufacturing to clinical experience,” said David Chang, executive vice president of research and development and CMO of Kite. “We firmly believe in the potential for axicabtagene ciloleucel to address this need and forge a new path for the future of cell therapy.”
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