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.
You can monitor the pharmaceutical pipeline in order to plan for changes with the Prescribe Right Pharmaceutical Pipeline Tracker.
Positive data was posted for iclaprim today in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Multi-drig resistant bacteria are common in ABSSSI. Several drugs are being developed for MDR infections. In addition to iclaprim, beta-lactams being developed include cefiderocol, ceftobiprole and sulopenem. Imipenem/cilastatin is also being tested in combination with the carbapenem dehydropeptidase relebactam. New antibiotics also include a systemic dosage of fusidic acid, new tetracyclines eravacycline and omadacycline and the pleuromutilin antibiotic lefamulin. Look for my review of new antibiotics in development for MDR in an upcoming issue of Hospital Pharmacy.
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