The approval for Abecma is based on data obtained from the Phase II Study BB2121-MM-001 and the Phase I Study CRB-401.
Bristol-Myers Squibb has received approval from Japan’s Ministry of Health, Labour and Welfare for its therapy Abecma (idecabtagene vicleucel) to treat relapsed or refractory (R/R) multiple myeloma in adults, according to an announcement.
Abecma is a chimeric antigen receptor (CAR) T cell immunotherapy directed by B-cell maturation antigen (BCMA).
In March last year, the company’s CD19-directed genetically modified autologous T cell immunotherapy Breyanzi received approval.
With the latest approval, Bristol Myers Squibb now has two approved CAR T cell therapies.
The Phase II study was conducted in Japan, the EU, the US and Canada. The personalised immune cell therapy Abecma, which received approval as a one-time infusion, identifies and attaches to the BCMA protein as an anti-BCMA CAR T cell therapy.
BCMA is universally expressed on multiple myeloma cancer cells and results in their death.
Till now, multiple myeloma has no approved therapeutic options in Japan.
Last August, the European Commission granted conditional marketing authorisation to Bristol Myers Squibb’s Abecma to treat relapsed and refractory multiple myeloma in adult patients.