FDA Orders Drugmakers , to Add Cancer Warning to , CAR-T Treatments.
This week, the Food and Drug Administration
ordered drugmakers to add a warning to
CAR-T cancer therapy, saying that the
treatment may increase the risk of cancer.
NBC reports that a spokesperson for the FDA
said that despite the warning being ordered, , "the overall benefits of these products
continue to outweigh their potential risks.".
According to spokesperson Carly Kemper,
the FDA's decision was prompted by reports of
CAR-T patients developing rare forms of blood cancer.
Kemper said that as of January 22,
the agency had recorded 25 cases of
CAR-T patients developing blood cancer.
NBC reports that CAR-T, short for chimeric
antigen receptor T cell, uses a patient's own
immune cells to treat certain types of blood cancers.
T cells are harvested, genetically
altered to make them target cancer cells
and then reinfused into the patient. .
According to experts, the treatment has
been highly effective in hard-to-treat cases. .
This has been a game changer
when we think about treating
lymphoma and other diseases, Dr. Matthew Frigault, clinical director of
the Massachusetts General Hospital Cellular
Immunotherapy Program in Boston, via NBC.
NBC reports that the first CAR-T
therapy received FDA approval in
2017 with Novartis' drug, Kymriah.
Another five drugs have
since received FDA approval