Newly-Approved Therapies and Pending Applications in Myeloma


Paul G. Richardson, MD, discusses the latest regulatory movement in the multiple myeloma space.

Paul G. Richardson, MD, clinical program leader and director for Clinical Research, Jerome Lipper Multiple Myeloma Center, institute physician at Dana-Farber Cancer Institute, and RJ Corman professor of Medicine at Harvard Medical School, discusses the latest regulatory movement in the multiple myeloma space, a topic he touched on during a presentation at the 3rd Summit of the Americas on Immunotherapies for Hematologic Malignancies.

According to Richardson, a large number of FDA approvals came through just before the COVID-19 pandemic. The approvals begin with belantamab mafodotin (Blenrep), Melphalan flufenamide (Melflufen), and chimeric antigen receptor T-cell therapies including idecabtagene vicleucel (ide-cel; Abecma), and ciltacabtagene autoleucel (cilta-cel; Carvykti).

In the near future, Richardson and other who treat multiple myeloma are anticipating FDA action for a bispecific antibody.


0:08 | Over the last several years we've seen a number of drugs approved, we start really just before the pandemic or just around the pandemic with belantumab mafadotin. And at the same time, we then had Melflufen approved. And then subsequent to that, and most recently, we had in addition to ide-cel’s approval, which was critical, which is the first CAR T platform, then the second CAR T platform, which was cilta-cel approved, which is extremely exciting.

0:35 | Plus multiple approvals around certain indications like for example, selinexor combined with bortezomib in the early relapse setting and other further indications for either isatuximab as a CD38-targeting antibody, and additional indications for CD38-targeting with daratumumab in different settings as well. So, I think there are multiple approvals, but probably the highlights would be the successes in the CAR T space, in particular either ide-cel and then very excitingly, and very recently cilta-cel.

1:07 | In the terms of belantumab mafadotin which targets BCMA as antibody-drug conjugate, that was some years ago now, but continuing to gain momentum. And then we did have the impressive approval of now Melflufen, a targeted peptide drug conjugate, although that's currently gone into a holding pattern pending some interpretation of important phase 3 data from a trial that showed different benefits in different subgroups of patients, which caught the regulator's attention appropriately and has generated some discourse and discussion about how to best go forward with that particular platform.

1:44 | Irrespective of that, we've got incredible work coming from bispecifics. These are antibodies that harness the immune system from within as it were, by basically targeting BCMA but at the same time harnessing a DT cell response dramatically to the target. And the bispecifics space I think is probably in the next to see an exciting new approval hopefully this year.

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