Abecma has been approved to treat adult relapsed and refractory multiple myeloma patients who have received a minimum of three prior therapies and have experienced disease progression on the last treatment.
The approval is based on data from the pivotal KarMMa trial, which saw participation of 128 relapsed and refractory multiple myeloma patients. The data showed a well-understood and predictable safety profile of the drug.
Patients involved in the KarMMa trial already received at least three treatments earlier.
According to the trial data, subjects receiving Abecma had an overall response rate (ORR) of 73%, while 33% of subjects achieved a complete response (CR).
BMS noted that the CMA for Abecma was granted under the European Medicines Agency PRIME (Priority Medicines) scheme.
Abecma is a chimeric antigen receptor (CAR) T-cell immunotherapy targeting B-cell maturation antigen (BCMA), a protein that is usually expressed on multiple myeloma cells.
The drug is being co-developed and co-marketed in the US by Bristol Myers Squibb and biotechnology company bluebird bio.
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.”