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 Ministry’s approval is based on safety and efficacy data obtained from the international Phase II Study BB2121-MM-001 and the Phase I Study CRB-401 conducted in the US.
The Phase II study was conducted in Japan, the EU, the US and Canada.
Bristol-Myers Squibb president and CEO Jean-Christophe Barland said: “Abecma delivers a new treatment option for patients with multiple myeloma, the first option directed against BCMA and using a new mode of action.
“This approval is a testament to our strong commitment to addressing unmet medical needs for patients in Japan. As a game-changer committed to ‘innovation with heart,’ Bristol Myers Squibb Japan will continue its efforts to help patients prevail over serious diseases.”
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.