The Food and Drug Administration has approved an advanced treatment for mantle cell lymphoma, a rare type of cancer that affects white blood cells. The one-time therapy, done by Gilead Sciences, is marked as Tecartus.
Because it is important: This is the third federal approval for a CAR-T therapy, a new era cancer treatment in which a person’s immune system cells are removed, reengineered, and then infused into the person’s bloodstream.
The panorama: The other CAR-T therapies on the market are Kymriah (made by Novartis) and Yescarta (also made by Gilead).
By the numbers: Gilead set the Tecartus list price at $ 373,000, the same as Yescarta.
- However, that doesn’t include other weird hospitalization costs.
- Both drugs were part of Kite Pharma, which Gilead bought in 2017 for almost $ 12 billion.
Between lines: Gilead said that 87% of people who received Tecartus in a clinical trial responded to the infusion, but almost one in five patients also experienced serious side effects associated with this type of immunotherapy.
- The trial was not randomized because cancer is rare and consequently the FDA required a warning about side effects and will closely monitor the therapy for safety concerns while it is on the market.
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