Newly Approved Therapies and Pending Applications in Myeloma

Paul G. Richardson, MD, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center, Institute Physician at the Dana-Farber Cancer Institute, and RJ Corman Professor of Medicine at Harvard Medical School, discusses the latest regulatory move in multiple myeloma, a topic he addressed during a presentation at the 3rd Summit of the Americas on Immunotherapies for Hematological Malignancies.

According to Richardson, a large number of FDA approvals were obtained just before the COVID-19 pandemic. 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 others who treat multiple myeloma anticipate FDA action for a bispecific antibody.


0:08 | Over the last few years we’ve seen a number of drugs approved, we’re really starting just before the pandemic or just around the pandemic with belantumab mafadotin. And at the same time, we then got Melflufen approved. And then afterwards, and more recently, we had the additional approval of ide-cel, which was essential, which is the first CAR T platform, and then the second CAR T platform, which was approved by cilta-cel, which is extremely exciting.

0:35 | More multiple approvals around certain indications such as selinexor combined with bortezomib in the setting of early relapse and other additional indications for isatuximab as an antibody targeting CD38, and additional indications for the CD38 targeting with daratumumab in different settings as well. So I think there are multiple endorsements, but the highlights would probably be the successes in the CAR T space, especially either ide-cel then very exciting, and very recently cilta-cel.

1:07 | As for belantumab mafadotin which targets BCMA as an antibody-drug conjugate, that was a few years ago now, but it continues to gain momentum. And then we had the impressive approval of now Melflufen, a targeted peptide drug conjugate, although it is currently on hold pending an interpretation of important phase 3 data from a trial that showed different benefits in different subgroups of Patients, which appropriately grabbed the regulator’s attention and generated discussion and discussion about how best to move forward with this particular platform.

1:44 | Regardless of that, we have amazing work coming from the bispecifics. These are antibodies that harness the immune system from within so to speak, essentially targeting the BCMA but at the same time dramatically harnessing a DT cell response to the target. And the bispecific space, I think, is probably next to see an exciting new endorsement, hopefully this year.

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