It looks as though the combination of bisantrene and carfilzomib could also qualify for breakthrough therapy designation status.
Two drugs were approved last year (Elranatamab and Talquetamab) for use in R+R MM after at least four lines of therapy. Both of these drugs were approved via the BTD pathway.
Considering carfilzomib is approved for use after two lines of therapy in R+R MM, any successful trial of bis and carf
would be a marked improvement over existing therapy so should be looked at as a worthy applicant.
Hopefully RAC can negotiate a deal with Amgen to make it happen.
Ann: Bisantrene Highly Active in a Multiple Myeloma Mouse Model, page-76
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