FDA approves third type of advanced cancer therapy
The Food and Drug Administration has approved an advanced treatment for mantle cell lymphoma, a rare type of cancer affecting white blood cells. The one-time therapy, made by Gilead Sciences, is branded as Tecartus.
Why it matters: This is the third federal approval of a CAR-T therapy, a new-age cancer treatment in which a person's own immune system cells are extracted, reengineered, and then infused back into the person's bloodstream.
The big picture: 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 list price of Tecartus at $373,000, the same as Yescarta.
- However, that does not include other extraneous hospitalization costs.
- Both of these drugs were part of Kite Pharma, which Gilead bought in 2017 for almost $12 billion.
Between the lines: Gilead said 87% of people who received Tecartus in a clinical trial responded to the infusion, but almost one out of five patients also experienced severe side effects associated with this kind of immunotherapy.
- The trial was not randomized because the cancer is rare, and consequently, the FDA required a warning for side effects and will closely watch the therapy for safety issues while it's on the market.