BMS’ Breyanzi Beats COVID-19 Constraints, Emerges As First RMAT Approval
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.
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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.
Dermatology, chronic kidney disease and liver disease therapies stand out in a crowd of user fee goals that is actually bigger than at the same point in 2020.
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.