The FDA approved Gilead’s CAR T-cell drug Yescarta on Oct 18. The annual cost of Yescarta has been set at $373,000, which is over $100,000 less than the $475,000 Novartis set for Kymriah, a CAR T-cell drug approved in August. However, Yescarta was approved for adults with relapsed or refractory large B-cell lymphoma a more prevalent form of cancer than twice-relapsed acute lymphoblastic leukemia (ALL) in children or young adults, which Kymriah received approval.
CAR T-cell drugs also have serious adverse effects that include cytokine release syndrome (CRS), a serious immune response and neurotoxicity. Health care professionals are working on protocols to recognize the adverse effects early in order to treat them and prevent the development of a more serious condition.
CAR T-cell drugs are patient specific treatment that involves a complex manufacturing process that takes 4 to 5 weeks to create a dose from the patient’s white blood cells. Companies are working on improving the process to try and decrease the time needed to create a dose to 3-4 weeks.
CAR T-cell drugs still in development include
JCAR017 being developed by Juno Therapeutics to treat leukemia and Non-Hodgkin lymphoma
bb2121 being developed by bluebird bio for the treatment of refractory multiple myeloma
LCAR-B38M being developed by Nanjing Legend Biotech to treat refractory multiple myeloma
You can read my review of CAR T-cell drugs in the July-August 2017 issue of Hospital Pharmacy.
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