Oncologists have a shopping CAR-T full of complaints, with safety questions for cell therapies No. 1

23 May 2024
www.fiercepharma.com
ImmunotherapyCell TherapyASCOClinical StudyDrug Approval
The FDA is investigating serious safety concerns around CAR-T therapies.
CAR-FDAell therapies have boomed in the past few years since the first FDA approval of this revolutionary new way of treating blood cancer back in 2017, but, while the technology has sped through, cancer doctors are feeling a little left behind.
That’s according to a new survey and report from IQVIA, timed to come oFDAalongside this year’s American Society of Clinical Oblood cancerO) cancer congress abstracts drop, which asked 100 CAR-T oncancersts about how well they felt informed about cell therapies.
Their biggest concern? Most oncologists who refer patients for CAR-T, coming in at 61%, spoke of a broad need for “more information about CARcancerl therapies,” according to the report.
When asked on an “unaided basis” what they specifically wanted, the most common request was for additional safety information (57%) around cell therapies.
CAR T-cell patients are treated at what are called “advanced treatment centers,” but, after they have completed therapy, they usually get referred to their original specialist for long-term monitoring.
IQVIA said the purpose of its report is “to measure if referring oncologists have the information required to safely manage CAR T-Cell patients.”
IQVIAtis’ Kymriah was the first CAR-T therapy approved in the U.S., for certain types of leukemia, and heralded the arrival of a new way of treating blood cancers. There are now six of these types of cell therapies on the U.S. market, which all work as a form of immunotherapy that sees a patient’s T cells removed, tweaked and then put back into their blood.
Novartiss Kymriah, these cells cCAR-Tth see and attack cancer cells, something that the bleukemiacally is blind to without this help. Some blood cancblood cancersan see amazingly efficacious results from this type of therapy.
While revolutionary, there have been safety issues, inccancer deaths in CAR-T trials. (Although this has not always been attributed to CAR-blood cancer
Most recently, the FDA last September began investigating what it called a “serious risk” of patients developing new cancers after treatment with these therapies. This was specific to patients who received BCMA- or CD19-directed CAR-T cell immunotherapies.
The FDA has since aFDAd secondary T-cell malignancy as a new boxed warning item on those CAR-Ts' labels, so it is percancerst surprising that cancer doctors want more safety information.BCMACD19-directedCAR-T cell
IQVIFDAlso asked 50 cancsecondary T-cell malignancyts using CAR-T what they need. Safety CAR-Tsropped up here, with one-third feeling “that thcancereds to be improved knowledge of the long-term safety aspects of CAR T-Cell therapies.”
IQVIAit came to simpcancererstanding more about CAR-T, nearly half (49%) of those doctors who refer patients said they “could use more information,” with just 10% saying they were “extremely well informed” and 12% saying “I need a lot more information.”
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