MHLW (Japan) approves Abcema to treat r/r multiple myeloma.
Abecma is the first CAR T cell therapy approved for the treatment of R/R multiple myeloma in Japan. With this approval, Bristol Myers Squibb is now the only company in Japan with two approved CAR T cell therapies—the CD19-directed Breyanzi, which received approval in March 2021, and the BCMA-directed Abecma.
The approval is based on efficacy and safety data sourced from the global Phase II Study BB2121-MM-001 conducted in Japan, the U.S., the EU, and Canada, and the Phase 1 Study CRB-401 in the U.S.
Despite advances in treatment, multiple myeloma remains an incurable disease, and many patients suffer through periods of remission and relapse. Until now there have been no approved therapeutic options in Japan for the treatment of multiple myeloma patients who have received three or more prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Consequently, there is a significant unmet medical need for novel, effective therapies.
Related news and insights
Otsuka Pharmaceutical Co., Ltd. announces that it has decided to terminate its global license agreements with Akebia Therapeutics, Inc. for vadadustat under development as an oral treatment for anemia associated with chronic kidney disease (renal anemia).
Aldeyra Therapeutics, Inc. reported that a post-hoc analysis using computer automated grading of digital photography from the completed Phase III TRANQUILITY dry eye chamber trial demonstrated statistical significance (p=0.020) in favor of reproxalap over vehicle for the primary endpoint of reduction of ocular redness.