BMS scores EU nod for Abecma as earlier myeloma treatment

2024-03-20

临床结果临床3期上市批准细胞疗法免疫疗法

Bristol Myers Squibb said Wednesday that Abecma (idecabtagene vicleucel) has become the first CAR-T cell therapy approved in the EU for use in an earlier line of treatment for patients with relapsed and refractory multiple myeloma.

Specifically, Abecma is now approved for adults who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last one.

The BCMA-targeting therapy was first approved in Europe in 2021 for use in the fourth-line setting. The latest decision is based on data from the Phase III KarMMa-3 trial, which enrolled 381 patients with relapsed/refractory multiple myeloma who had received two to four prior lines of treatment.

Results showed that Abecma cut disease progression or death by 51%, compared to standard treatments. Median progression-free survival for Abecma was 13.3 months, versus 4.4 months for the comparator arm.

"With a significant increase in manufacturing capacity and over 90% manufacturing success rate globally, Bristol Myers Squibb is prepared to meet increased demand for Abecma," the company said Wednesday, noting that it "is focused on making Abecma available in the EU for this [earlier-line] indication, including completion of reimbursement procedures."

Bristol Myers Squibb is seeking a third-line label in the US as well. Last week, an FDA advisory panel voted 8-3 that Abecma's risk-benefit profile based on the KarMMa-3 results is favourable despite concerns voiced by agency staff about a possible increased risk of early death. FDA staff had flagged similar issues with Johnson & Johnson's Carvykti (ciltacabtagene autoleucel), which was also discussed at the meeting.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构