Silver Spring, Maryland – An FDA advisory committee voted overwhelmingly in favor of recommending the approval of CAR-T therapies from Johnson & Johnson, Legend Biotech, Bristol Myers Squibb, and 2seventyBio for the treatment of multiple myeloma. The committee’s support for these therapies highlights a significant milestone in the ongoing discussions surrounding the use of CAR-T treatments in cancer care.
During the committee meeting, concerns were raised about the higher rate of early deaths observed in the trials of Carvykti and Abecma. However, despite these concerns, the committee members ultimately agreed that the potential benefits of these therapies outweigh the risks associated with early mortality. The promising results in terms of progression-free survival and overall survival were cited as key factors in their decision to support the approvals.
Experts in the field, including William Gradishar and Neil Vasan, emphasized the importance of considering the small risks of early deaths in the context of the substantial benefits that CAR-T therapies can offer to patients with multiple myeloma. Their insights underscored the complexity of assessing the risk-benefit profile of these innovative treatments.
While some committee members expressed reservations about certain aspects of the data presented, including concerns about overall survival trends and treatment response durability, the majority agreed that the potential for prolonged progression-free survival and improved quality of life for patients justified their support for the approvals.
In response to the committee’s recommendations, representatives from Johnson & Johnson and Bristol Myers Squibb expressed confidence in the efficacy and safety profile of their respective CAR-T therapies. They highlighted the importance of expanding treatment options for patients with relapsed/refractory multiple myeloma and emphasized the potential of CAR-T therapies in earlier lines of treatment.
The FDA’s ongoing investigations into the safety of CAR-T therapies, including the risk of secondary malignancies, have prompted increased scrutiny of these treatments. Despite these challenges, oncologists remain optimistic about the benefits of CAR-T therapy in improving patient outcomes and potentially transforming the way certain cancers are treated.
Moving forward, the FDA will continue to evaluate the data on Carvykti and Abecma, considering the advisory committee’s recommendations as it determines the appropriate course of action regarding the approval of these CAR-T therapies for multiple myeloma. The ongoing dialogue between regulators, healthcare providers, and industry stakeholders underscores the complex nature of decision-making in the rapidly evolving field of cancer treatment.