The U.S. Food and Drug Administration (FDA) has issued a stern warning associated with the potential risks of certain cancer therapies. These treatments, despite their proven effectiveness in combating existing cancers, have been linked to the development of new, different types of cancer. The FDA's warning targets healthcare providers and patients, aiming to ensure informed decisions about cancer care are made.
FDA's Investigation into CAR-T Therapies
The FDA has disclosed the investigation of 19 reported cases of new cancer linked to CAR-T therapies. These therapies involve the removal and genetic modification of T cells from a patient's blood, introducing CARs which may disrupt cell DNA and trigger other cancers. Despite the potential risks, the FDA has emphasized the benefits of the treatment, reiterating that they still outweigh the risks. Patients undergoing CAR-T therapy are advised to undergo lifelong monitoring for new malignancies. The approved treatments under scrutiny include those developed by Gilead Sciences, Johnson & Johnson, Bristol Myers Squibb, and Novartis.
Impact on Blood Cancer Treatments
The FDA's investigation primarily focuses on cell therapies used to treat blood cancers, with growing concerns that these treatments may cause additional malignancies. Particularly, the impact of CAR-T therapy is under study, where immune cells are genetically engineered to bind to cancer cells and eliminate them. These high-priced therapies are commonly used in hard-to-treat lymphomas and other blood cancers.
Comparative Risks of Cancer Therapies
Initially, the FDA's investigation into whether CAR-T immunotherapy causes blood cancers seemed to be a significant setback to cancer care. However, experts caution that the risk of this complication is probably minuscule compared to the known risk of secondary cancers from other cancer therapies like chemotherapy and radiation. Given that CAR-T was invented more than 10 years ago, the risk had remained theoretical until now.