Advisers Vote in Favor of Earlier Treatment for Multiple Myeloma Patients

In a significant development for blood cancer patients, an advisory panel to the U.S. Food and Drug Administration (FDA) has voted to support the expanded use of Johnson & Johnson (J&J) and Bristol Myers Squibb's innovative CAR-T cell therapies. The decision paves the way for these treatments to be administered to multiple myeloma patients at an earlier stage, potentially benefiting those who are less severely affected by the disease.

Unanimous Support for J&J's Carvykti

The 11-member panel unanimously agreed that the benefits of J&J and Legend Biotech's Carvykti outweighed the risks when given as an earlier treatment option. Panelist Mary Kwok highlighted the importance of providing patients with a one-time treatment that eliminates the need for frequent hospital visits, stating, "To be able to give a one-time treatment (to patients) and without requiring them to come back and forth is a really important option."

Mixed Votes for Bristol's Abecma

While Carvykti received unanimous support, Bristol's Abecma faced a more divided panel. Eight out of the 11 members voted in favor of its earlier use. The FDA staff reviewers raised concerns about a pattern of early deaths observed in late-stage studies of both therapies, which Bristol attributed to disease progression rather than the treatment itself.

Addressing Concerns and Moving Forward

Despite the concerns raised, several panelists noted that the cause of early deaths in the Carvykti trial was unclear and unlikely to be related to the therapy. J&J explained that some of these deaths occurred while patients were receiving bridging therapy before Carvykti administration.

The FDA is expected to make a final decision on the early use of Carvykti. While the agency usually follows the advice of its panel, it is not obligated to do so.

While concerns about early deaths in clinical trials were raised, the potential to provide a one-time, life-changing treatment cannot be overlooked. As the FDA moves closer to a final decision, the implications for patients, healthcare providers, and the pharmaceutical industry are profound.

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