FDA okays Abecma for earlier multiple myeloma as Carvykti decision looms

2024-04-05

临床结果上市批准临床3期细胞疗法免疫疗法

The FDA on Thursday cleared Bristol Myers Squibb and partner 2seventy bio's CAR-T therapy Abecma (idecabtagene vicleucel) for adult patients with relapsed or refractory multiple myeloma (MM) after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

The decision was announced ahead of another likely approval expected Friday, this one for Johnson & Johnson and Legend Biotech's rival CAR-T therapy Carvykti (ciltacabtagene autoleucel) as a potential second-line treatment option.

Abecma was approved in 2021 for relapsed/refractory MM in patients who had undergone at least four prior therapies. Bristol Myers Squibb has been looking to move it into the third-line setting based on data from the Phase III KarMMa-3 study, which met its primary endpoint, reducing the risk of progression or death by 51%.

"Abecma has demonstrated a progression-free survival benefit three times that of standard regimens … and we are now bringing the promise of cell therapy to patients earlier in their treatment journey," said Bryan Campbell, head of commercial for cell therapies at Bristol Myers Squibb.

The approval follows a positive vote from an FDA advisory committee (adcom) last month, albeit with some concerns raised about an imbalance in early deaths associated with Abecma, as well as Carvykti, compared to standard care in their respective pivotal trials. FDA staff had also flagged the early death signal in briefing documents released ahead of the adcom.

Bristol Myers Squibb attributed the imbalance to patients who had not yet actually received Abecma in KarMMa-3, and hinted that the study's crossover design and the impact of bridging therapies likely influenced the survival data.

Abecma was recently approved in Japan, Switzerland and the EU for use in the third-line setting. It is also currently authorised in Great Britain and Israel for fourth-line patients with triple-class exposed relapsed and refractory MM.

There is a growing willingness among key opinion leaders to move BCMA-targeting CAR-Ts such as Abecma and Carvykti up the treatment algorithm for MM. A recent poll by FirstWord found that nearly 40% of US haematologists and oncologists surveyed were already considering CAR-Ts or bispecifics as first- or second-line treatment options.

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