EU Review Time Lengthens for BMS’s CAR-T Therapy Liso-Cel
Company Wants More Time To Answer Reviewers’ Questions
Bristol Myers Squibb's marketing application for liso-cel is in the final stages of the review process at the European Medicines Agency. The agency’s drug evaluation committee, the CHMP, adopted in mid-April the list of concerns it has with the application.
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BMS Touts Breyanzi's Outpatient Administration As EU Approval Beckons
The US major won a positive opinion from the EU CHMP for Breyanzi with hopes the advantage of outpatient administration could help combat the lack of market impetus for CAR-T therapies.
Incyte/MorphoSys Await EU Verdict On Tafasitamab For DLBCL
Is the benefit-risk profile of tafasitamab good enough for it to be recommended for EU-wide marketing approval? Codevelopers Incyte and MorphoSys may find out this week.
BMS/bluebird’s Ide-Cel: EU Decision Time On First CAR-T For Multiple Myeloma
The European Medicines Agency will decide this week whether BMS and bluebird bio’s cell-based gene therapy for multiple myeloma should be approved for use in the EU.