CAR-T Therapy Can Cause Secondary Tumors, FDA and EMA Announce
CAR-T therapy has been a groundbreaking advancement in the treatment of cancer, particularly in the case of incurable blood cancers. Patients who had previously not responded to other treatments are now experiencing a new lease on life. However, recent announcements from the American Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are causing concern over the safety of CAR-T therapies.
The FDA made a statement on November 28, warning that CAR-T therapies can lead to secondary tumors. This news was followed by a similar announcement from the EMA, which has initiated a review into the safety of CAR-T therapies.
There are currently six CAR-T therapies approved in the European Union, with three of them also available in Italy. These therapies have been authorized for patients with various types of lymphoma and leukemia, and further approvals are expected in the near future.
CAR-T therapies involve taking T lymphocytes from a patient’s blood, reengineering them in a laboratory to better recognize and attack cancer cells, and then reintroducing them into the patient’s bloodstream. Despite the promising results, the therapies come with serious side effects and require highly specialized medical staff to manage them.
The concerns over secondary tumors were raised after 23 cases were reported in patients who received CAR-T therapies. However, Fabio Ciceri, a leading expert in the field from the IRCCS San Raffaele Hospital in Milan, reassures patients that the current benefits of CAR-T therapies far outweigh the potential risks. He notes that the occurrence of secondary tumors is very rare and that regular checks at treatment centers are already part of the standard protocols for CAR-T therapies.
Both the FDA and EMA have emphasized that the current benefits of CAR-T therapies remain significant, and any potential risks are outweighed by the potential benefits. They have also highlighted that monitoring for side effects, including secondary tumors, is a standard procedure for all authorized medications.
Ciceri acknowledges that while the potential risk of secondary tumors was known at the time of the therapies’ authorization, the exact causes and factors influencing this complication are still not fully understood. However, through continued clinical observation and specialized biological analyses, it is hoped that the true incidence of secondary tumors can be better understood and managed.
In conclusion, patients who have already received CAR-T therapy are reassured that their treatment centers are already conducting regular checks as part of the routine management protocols for these therapies. And while the concerns over the safety of CAR-T therapies are important, the potential benefits of these innovative treatments are still significant in the fight against cancer.