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Video
What BCMA therapies have been approved in myeloma?
Posted by
HealthTree • March 1, 2024
Description
Learn about approved BCMA therapies in myeloma in this video.
On this video
Transcript
What BCMA therapies have been approved in myeloma? Who is the target population for each? So, currently here in the United States, the FDA has approved three BCMA targeting therapies for patients with relapsed and refractory myeloma. So, that's patients whose myeloma has come back after a number of lines of therapy, and I'll get into the specifics of that in So, there are two cellular products and one bispecific. So, the cellular products are where we take the patient's own T cells, they get sent away for manufacture, and they get genetically engineered to express on their surface a targeting molecule that binds to BCMA and then excites the T cell that it's attached to so that it is more likely to divide, expand and attack the tumor. The two cellular products that we have available that are FDA approved are called IDA cell or a BCMA, that's the trade name, and Ciltacell or Curvicti, that's the trade name. And both of those have the same patient population as well as the bispecific which is called Teclistomab or Tecvaili, that's the trade name. And that one is slightly different in that we don't need the patient's own immune cells, we actually, it's an off-the-shelf product and it's a bispecific antibody. So, it has two arms, one arm binds to the myeloma cells, the BCMA on the myeloma cells, and the other arm binds to CD3 on the T cells and it brings those things together. So, it's requiring the patient's own T cells to come over and attack the tumor, the attack the plasma cells and flag them for destruction as well. Since the recording of this video, the Food and Drug Administration granted accelerated approval to Elronatumab BCMM, a bispecific B cell maturation antigen-directed CD3 T cell encager. And those three products are all licensed and approved in exactly the same patient population. So, the patients have to have received our three big main classes of agents. So, one of them are immunomodulator reagents, so things that you'd have heard of are lenalidomide or Revlimid, thalidomide or pomalidomide or pomelist. So, that's one class, immunomodulators. The other class that they have to have been exposed to at some point during their disease are called proteasome inhibitors. There's a bunch of those two. One of them is called Velcade or rortesomib. The other one is called Kyprolis or carfilzomib. And the other one that you can sometimes get exposed to is exasomib or nilaro. And then the third agent that they should have seen at some point in their disease prior to getting these agents is an anti-CD38 antibody. So, those are inclusive of daratumumab or darzalex or esatuximab and sarclizas, that one's called. So, once they've seen the big three, so those three classes of drugs, and they have to have had four prior lines of therapy, so they have to have had four discrete packages of care, then they are eligible for those agents. So, sometimes it's quite tricky for patients to get their heads around when they could get access because, for example, the initial therapy, the transplant and the maintenance, that only classifies as one line of therapy. And so, it's important for patients not to think that each piece is a line of therapy, that actually that's just one line. But then everything they have after that usually constitutes a line, especially if they're on, let's say, two drugs and then their myeloma isn't responding that well. If another drug gets added, that's a line, that counts. Whereas if they're on something, something gets taken away, that doesn't really count as a line, if you know what I mean. So, it's not an additional line then. So, it can be tricky and that's why the doctors that see patients for these agents are quite picky about going through the history and understanding what patients have had in the past to make sure that they meet the indication. But once they've had those big three and four lines, they're eligible for those products.
