The European Commission (EC) has granted conditional marketing authorization (CMA) to Bristol Myers Squibb’s (BMS) Abecma (idecabtagene vicleucel; ide-cel) to treat adult relapsed and refractory multiple myeloma patients.
The approval is for patients who have had a minimum of three previous therapies and experienced disease progression on the last treatment.
Abecma is a chimeric antigen receptor (CAR) T-cell immunotherapy targeting B-cell maturation antigen (BCMA), a protein usually expressed on multiple myeloma cells.
The drug detects and attaches to BCMA causing CAR T cell proliferation, cytokine secretion, and cytolytic destruction of BCMA-expressing cells.
Abecma is the first-ever BCMA-targeting CAR T-cell treatment to obtain approval, BMS noted.
Bristol Myers Squibb chief medical officer Samit Hirawat said: “The EC approval of Abecma is an important milestone for the treatment of multiple myeloma and moves us closer to offering a first-in-class, personalised therapy to patients in Europe battling this incurable disease after exhausting prior treatment options with the three standards of care.
“With this third regulatory approval for Abecma worldwide, we are proud to be advancing the science of cell therapy and continuing to bring this first anti-BCMA CAR T cell therapy to patients in need.”
The CMA for Abecma was granted under the European Medicines Agency PRIME (Priority Medicines) scheme.
The approval is based on data from the pivotal KarMMa trial which showed a well-understood and predictable safety profile of the drug.
The trial enrolled 128 relapsed and refractory multiple myeloma patients who already received at least three treatments earlier.
Data from the trial showed that subjects receiving Abecma had an overall response rate (ORR) of 73%, while 33% of subjects attained a complete response (CR).
Response onset was quick, with a median time to response of one month and was maintained for a median duration of response (DOR) of 10.6 months, BMS added.
For patients who attained a CR, the median duration of response was 23 months.
The drug received approval in the US in March this year to treat relapsed or refractory multiple myeloma in adults who received four or more prior treatments.
Abecma is being co-developed and co-marketed in the US by BMS and bluebird bio.
The latest development comes after BMS opted to in-license an immune-modulating drug candidate developed by Exscientia.