Oncologists Criticize CAR-T Therapies, Cite Safety Concerns

CAR-T cell therapies have seen rapid advancements since the FDA's first approval in 2017 for treating blood cancers. Despite the enthusiasm, cancer specialists feel they are lagging behind in terms of knowledge and understanding of these advanced treatments.

A recent survey by IQVIA, released in conjunction with the American Society of Clinical Oncology (ASCO) cancer congress abstracts, surveyed 100 oncologists specializing in CAR-T therapies. The findings revealed significant concerns about the adequacy of information available to these professionals. According to the report, 61% of oncologists who refer patients for CAR-T therapy expressed a need for more comprehensive information on CAR-T cell therapies. Specifically, 57% of these oncologists requested additional safety data regarding these treatments.

CAR-T therapies are administered at advanced treatment centers, but patients typically return to their original oncologists for long-term monitoring after treatment. IQVIA's report aimed to assess whether referring oncologists have sufficient information to manage CAR-T patients safely in the long run.

The first CAR-T therapy approved in the U.S. was Kymriah by Novartis, targeting specific types of leukemia. This milestone marked the beginning of a new era in treating blood cancers. Currently, six distinct CAR-T cell therapies are available on the U.S. market. These therapies function as a form of immunotherapy, involving the extraction, modification, and reinfusion of a patient's T cells to enable them to recognize and attack cancer cells. The efficacy of CAR-T therapies has led to remarkable outcomes for some blood cancer patients.

Despite their revolutionary impact, CAR-T therapies have encountered safety challenges, including fatalities during clinical trials. In some instances, these adverse events were not directly linked to CAR-T treatment. In September of the previous year, the FDA initiated an investigation into the "serious risk" of secondary cancers developing in patients treated with CAR-T therapies, particularly those targeting BCMA or CD19. Consequently, the FDA has mandated the inclusion of secondary T-cell malignancy as a boxed warning on the labels of these CAR-T products. This development has further emphasized the need for more safety information among oncologists.

IQVIA extended its inquiries to 50 cancer doctors who treat patients with CAR-T therapies. Safety concerns were again highlighted, with one-third of these doctors emphasizing the necessity of better understanding the long-term safety aspects of CAR-T therapies. Additionally, nearly half (49%) of doctors who refer patients for CAR-T treatment acknowledged that they needed more information about these therapies. Only 10% felt "extremely well informed," while 12% indicated a significant need for additional information.

In conclusion, while CAR-T cell therapies have brought groundbreaking advancements in the treatment of blood cancers, the rapid pace of innovation has left many oncologists seeking more comprehensive information. Safety concerns, particularly regarding the long-term effects of these therapies, remain a significant issue. The FDA's ongoing investigations and the addition of new warnings on CAR-T product labels underscore the importance of addressing these concerns to ensure the safe and effective use of CAR-T cell therapies.

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