Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
95.7% of patients responded to Breyanzi in the TRANSCEND FL trial
This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Cobenfy generated $43 million in third-quarter sales, up from $35 million in the second quarter
Acquisition includes OTX-201, an investigational next-generation CAR T-cell therapy designed to reprogram cells in vivo with potential best-in-class profile for autoimmune diseases
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm
It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan
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