The European Commission (EC) has approved Bristol Myers Squibb/bluebird bio’s first-in-class anti-B-cell maturation antigen (BCMA) CAR T cell therapy Abecma (idecabtagene vicleucel) for patients with relapsed and refractory multiple myeloma who have received at least three prior therapies.
Abecma is the first CAR T cell therapy that is directed to recognise and bind to BCMA, a protein that is almost always expressed on cancer cells in multiple myeloma, and leads to the death of BCMA-expressing cells.
When a patient’s cancer is no longer responding to their current treatment regimen or the patient relapses, multiple myeloma becomes increasingly difficult to treat.
“In the KarMMa trial, treatment with ide-cel proved to elicit deep and durable responses in a significant proportion of patients with triple-class exposed multiple myeloma, including many who were heavily pretreated and had high-risk disease,” said Jesus San Miguel, medical director of the Clinica Universidad de Navarra, Navarra, Spain and KarMMa clinical trial investigator. “The approval is important for patients in Europe, as it represents another potential therapeutic option for clinically meaningful outcomes and long-term disease control.”
“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,” said Samit Hirawat, chief medical officer, Bristol Myers Squibb.
BMS has raised the possibility of a European-based manufacturing facility in Leiden, Netherlands to help make Abecma commercially available to patients in the EU.
Abecma was authorised in the US in March for use in adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy. The FDA initially issued a refuse-to-file letter in May 2020, asking BMS and bluebird bio for additional data.