US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.

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. 

Thirteen of the 20 new active substances that were approved in the EU between January and April this year have also now received regulatory clearance in Great Britain, Pink Sheet analysis finds. New filing procedures have been in place there since 1 January.

Market Snapshot: GSK's Blenrep and BMS's Abecma are the first of many drugs for the late-line setting. In many cases, the CAR-T may be the first choice, but some patients are unable to handle it or risk progressing while awaiting treatment.