Connect with us

Hi, what are you looking for?

Business

FDA warns of secondary cancer risk tied to CAR-T therapies that treat cancer

The US Food and Drug Administration (FDA) has recently issued a significant warning concerning potential risks associated with a type of immunotherapy known as chimeric antigen receptor T-cell (CAR-T cell) therapy. Letters have been sent to various manufacturers instructing them to include a “boxed warning” in the prescribing information for these therapies.

This cautionary note highlights instances where T-cell malignancies have emerged after patients received BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. While the FDA acknowledges these risks, it underscores that the overall benefits of these products outweigh any potential downsides.

As of the latest update on Monday, the FDA has received reports of 25 cases of T-cell malignancies following CAR-T cell immunotherapies. T-cells, crucial components of CAR-T therapies, are modified in a lab to target cancer cells, and the modified cells are then reintroduced to the patient through an infusion.

Carly Pflaum, an FDA spokesperson, emphasizes the need for lifelong monitoring of patients undergoing these therapies for any signs of new malignancies. In the event of new malignancies, healthcare providers are advised to reach out to the manufacturer for guidance on sample collection and testing.

While the specific risk of developing treatment-induced T cell lymphoma post-CAR-T cell therapies is considered low, experts suggest that the updated safety label from the FDA is likely to spur the development of even safer versions of these therapies in the future.

In November, the FDA launched an investigation into the risk of secondary cancers associated with specific CAR-T cell therapies. By the end of last year, the agency had received reports of 22 cases of T-cell malignancies, with over 27,000 individuals having been treated with these therapies in the United States.

Despite acknowledging these risks, healthcare professionals stress that the substantial benefits of CAR-T cell therapies outweigh any potential drawbacks, particularly for patients dealing with relapsed or refractory blood cancers. The FDA intends to adapt and update its information as more data becomes available in the coming months. Keep an eye out for further developments in this evolving healthcare landscape.

Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

You May Also Like

Technology

Apple is gearing up for a significant refresh of its iPad lineup in 2024, starting with the anticipated launch of the iPad Pro in...

Business

Shareholders made significant decisions on Thursday regarding the leadership of Norfolk Southern, one of the largest railroads in the United States. While three of...

Business

Microsoft Teams had a major hiccup on Friday, causing disruptions and various issues for users. The problem started around 11 a.m. EST and quickly...

Entertainment

Olivia Rodrigo’s Guts World Tour is gaining attention not only for her musical prowess but also for her distinctive fashion choices on stage. Styled...