EU Fast-Track Fail For Another BMS CAR-T Cell Therapy
EMA Review Of Ide-Cel Reverts To Standard Timelines; Orva-Cel Development Program Scrapped
Bristol Myers Squibb says it is common for cell and gene therapies to revert to the standard timetable as ide-cel follows liso-cel in losing its accelerated assessment status at the European Medicines Agency. Separately, the company has discontinued development of orva-cel, a CAR-T cell therapy that was earlier in the development pipeline.
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New medicines under evaluation at the European Medicines Agency.
Breyanzi’s list price is $410,300. The CD19-targeting CAR-T therapy previously known as liso-cel has a lot of ground to make up following competitors Yescarta and Kymriah.
After missing user fee date due to inspection delay, US FDA clears the CAR-T therapy for treatment of adults with relapsed or refractory large B-cell lymphoma.