- The FDA received reports of new cancers in patients receiving CAR-T therapy
- However, it said the overall benefits of these products outweigh the potential risks
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A life-saving cancer therapy may actually cause new diseases in patients who receive the treatment.
The Food and Drug Administration said Tuesday it is investigating reports of 19 cases of new cancer linked to CAR-T therapies, which are given to terminal blood cancer patients.
The treatment involves taking immune cells from the body and developing them to attack tumors before reintroducing them into the patient’s blood.
Experts say the groundbreaking treatment has saved the lives of thousands of patients since its approval in 2017.
But the way it is administered can disrupt cell DNA and lead to other cancers, which is a small risk with all so-called gene therapies.
An illustration of a T cell, blue, attacking a cancer cell, red
CAR-T therapies, or chimeric antigen receptor T cell therapies, were first approved in November 2017 and are reserved for cancer patients who would otherwise die without this therapy
The FDA says the small number of cases – not proven to be caused by CAR-T – compared to the number of lives the treatment has saved means the benefit still far outweighs the risk.
It is not unheard of that cancer treatments, paradoxically, carry a small risk of developing new cancers, while radiation and chemotherapy are both known to do so.
CAR-T therapies, or chimeric antigen receptor T-cell therapies, were first approved in November 2017 and are reserved for cancer patients who would otherwise die without the therapy.
The treatment involves removing a type of white blood cell (T cells, which help the body fight disease) from a patient’s blood and genetically engineering them to make CARs.
CARs are proteins designed to give T cells the new ability to target a specific toxin. In the case of CAR-T therapies, scientists insert the gene for CARs into a patient’s T cells, which then allows the T cells to attach to and kill cancer cells.
The National Cancer Institute estimates that there will be approximately 60,000 new cases of leukemia in 2023, resulting in more than 20,000 deaths.
A third of patients with blood cancer die within five years of diagnosis.
The Leukemia and Lymphoma Society estimates that 90,000 people will be diagnosed with lymphoma, a cancer of the lymphatic system that includes Hodgkin (HL) and Non-Hodgkin (NHL) lymphoma, and that an estimated 21,000 people will die from the disease. The five-year survival rate for HL is 96 percent and 85 percent for NHL.
Myeloma, another form of blood cancer, is expected to affect 35,000 people and cause 12,500 deaths. The five-year survival rate is 77 percent.
The FDA added that it will investigate the risk of new blood cancers, including the possibility of hospitalization and death. The need for regulatory measures will also be assessed.
As with all gene therapies, the potential risk of developing secondary cancer is a caveat to approved treatments.
The FDA said patients and people who receive the therapy as part of a clinical trial should be “monitored for life for new malignancies.” If disease does occur, prescribers should contact the manufacturer immediately and perform tests to see if the new cancer contains CAR proteins.
Approved treatments include those developed by Gilead Sciences, Johnson & Johnson, Bristol Myers Squibb and Novartis.
Gilead said it was working with the FDA at the agency’s request for an analysis of the company’s data. It said there was no evidence that either of the two therapies they developed – Tecartus and Yescarta – played a causal role in the development of new cancers.
Gilead told Reuters: ‘We are confident in the overall safety profile of both Tecartus and Yescarta.’