What FDA approved treatments are available treatments for patients with RRMM with received two or more prior lines of therapy?

What FDA approved treatments are available for patients with relapsed refractory multiple myeloma who have received two or more prior lines of therapy.

we are in a time for multiple myeloma where we have the luxury of having a lot of treatment options and it's not necessarily one size fits all.

So after first relapse, after a second relapse, we have a lot of agents you can go for.

So a cd38 monoclonal antibody, these would be drugs like daratumumab or isatuximab in combination with things like carfilzomib or pomalidomide or even lenalidomide, depending on what you are relapsing from.

So rather than saying, you know, this drug is what you get after first line, this is what you get after second line.

I think it's really saying we have a lot of options that you can choose from.

It's really important to weigh, you know, what were you on right before, what treatment are you relapsing off of in general? You know, for example, if you're on maintenance, lenalidomide after your stem cell transplant, it's your first relapse and your relapsing off of that lenalidomide, I probably would use something different than a lenalidomide or maybe even different than an immunomodulatory agent in general.

So potentially something like Daratumumab or isatuxumab plus maybe a proteasome inhibitor might be the route to go. I think you also have to factor in side effects, the side effects of the drugs that you want to get, what side effects you have from prior therapies that we have to manage. So if you have peripheral neuropathy that's really bad from your first line or second line therapy, I probably would not want to incorporate that into your next line of therapy.

If you have a history of, you know, having a heart attack and you have stents placed, you cardiovascular disease, certain types of proteasome inhibitors like carfilzomib may not be the direct medicine to go to. So I think that we have a lot of options for first, second, third line. And it's a matter of combining those to the best ability in terms of efficacy, but also patient profiles.

And then I think in particular, you know, drugs like CAR-T cell therapy or bispecific T-cell therapies, those for sure are only right now indicated for people who've had four or more prior lines of therapy.

But all of our other agents say for the most part, you can kind of get after your first relapse,

On April 5th, 2024, the FDA approved new indications for both CARVYKTI and ABECMA. The FDA approved CARVIKTY for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.

The FDA approved ABECMA for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and an anti Cd38 monoclonal antibody.

So given the mechanism of actions that we currently have for myeloma patients, we are starting to think more about prior drug exposure and prior refractoriness two different drugs and classes of therapies.

For our patients who are relapsing for the first time, we have many different options, mostly three drug or triplet combinations that are based with either immunomodulatory drugs like Lenalidomide and pomalidomide or Proteasome inhibitors like Bortezomib or carfilzomib, and there are combinations with anti CD38 monoclonal antibodies like daratumumab or isatuxumab.

So all in all, we have many different treatment options for our patients when it comes to the first relapse.

As patients get into the second relapse and beyond, the disease starts becoming, you know, a little bit more difficult to treat and our options kind of become limited. So we try to pick treatments that patients may have not seen before.

And it also makes sense. You know, we want to make sure that they work for the patient who has had prior exposure to, certain therapies. So so it's not a one size fits all. You know, it's it's a lot of different decisions that, you know, or factors that go into that decision making. The other good news is, you know, that whole landscape of, you know, one or second or beyond relapse is changing very rapidly.

And that's good news for patients. You know, the options we have today are going to be very different from the options we have a year from now.

some of the immune therapies that are being developed that we have developed for later lines of treatment will likely be moving into earlier lines of treatments.

So that will make our decision tree a little different.

And but that's all good for our patients.

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