Saturday 28/June/2025 – 07:02 PM
The US Food and Drug Administration announced the cancellation of the risk assessment program known as REMS, which was previously imposed on all CAR-T treatments, advanced immune treatments used to combat specific types of cancer, according to Reuters.
The United States cancels the strict safety procedures for cancer treatments with immune cells CAR-T
The decision came after a scientific review that confirmed that the risks associated with treatments can be managed effectively through warnings and posters associated with medicines, which include detailed information about symptoms such as cytokin release syndrome and nerve heaven.
Drugs affected by the decision include treatments from major companies such as Breyanzi and Abecma, Johnson & Johnson (Carvykti), NoMriah, and Jellad Sains (Yescarta and Tecartus).
Gallad has confirmed that it has already updated the pharmaceutical posters to reflect this change, explaining that removing restrictions will contribute to reducing the burden on patients and health care providers, which facilitates access to life -saving treatments.
Stem cell treatment mechanism
CAR-T technology depends on extracting immune cells from the patient, then adjusting them genetically outside the body to be able to attack cancer cells, before re-injected with the patient.
Pharmaceutical companies and specialists believe that this decision represents an important step towards accelerating the availability of advanced treatments for cancer patients, especially those with blood cancers that do not respond to traditional treatments.
