- The FDA just approved a cutting-edge therapy to treat more patients with certain forms of blood cancer.
- It's the second approval for the drug, Kymriah, which is now approved to treat certain forms of leukemia and lymphoma.
- The therapy works by taking a person's own cells, reprogramming them, and inserting them back into the body to fight the cancer — in this case, certain forms of blood cancer.
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A cancer treatment that one expert called the 'most exciting thing I've seen in my lifetime' just got approved to treat more patients (NVS, GILD)
The FDA just approved a cutting-edge therapy to treat more patients with certain forms of blood cancer. It's the second approval for the drug, Kymriah, is now approved to treat certain forms of leukemia and lymphoma.
"I think this is the most exciting thing I've seen in my lifetime," said Dr. Tim Cripe, an oncologist who was part of the FDA advisory committee panel that voted in July to recommend the drug's initial approval.
The approval now puts Kymriah, made by Novartis, into direct competition with Yescarta, another CAR-T cell therapy that was approved in August made by Kite Pharma, a company Gilead Sciences acquired in 2017.
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Yescarta and Kymriah aren't your run-of-the-mill pill — or even abiologic drug, like insulin — that can be mass produced. Since the therapy is made from a person's own immune system, the process can take about three weeks.
list price of $373,000, and Kymriah will have the same price for patients with large B-cell lymphoma.$475,000 price tag for patients with pediatric leukemia
A big new field of medicine
Kymriah, and Yescarta are the first two CAR-T cell therapies to get approved, and several more are in the works.Juno Therapeutics, and Bluebird Bioare among a growing group of biotech companies working with CAR-T.
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"We're at the very beginning of what's going to be a big new field of medicine," David Epstein, who helped license Kymriah from the University of Pennsylvania while at Novartis told Business Insider in August.
Epstein left Novartis in 2016 as CEO of its pharmaceuticals divisions. He's now the executive chairman of Rubius Therapeutics, a biotech firm that's also working with cell therapy to develop treatments like Kymriah that don't have to be as personalized. The hope is that one day doctors will be able to prescribe a cell therapy and use it that same day instead of waiting weeks to get it back, and possibly extend beyond the blood cancers treatments like Kymriah and Yescarta are able to treat.
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