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Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy

Liso-cel Review Will Take Longer Than Anticipated in EU As Well As In US

Executive Summary

The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.

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Three Cell And Gene Therapies Reach Critical Review Stage In EU

A number of advanced therapies are likely to be approved in the EU this year.

EU Fast-Track Fail For Another BMS CAR-T Cell Therapy

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.

Breyanzi Is Third To Market, But BMS’s First CAR-T Therapy Priced Above Competitors

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. 

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