I think for renal impairment, you have to have several thoughts in your head at the same time. One is that the higher the efficacy of the drug is, the faster the situation in the patient gets better with lower light chains, which makes it possible to increase renal function if that was caused by myeloma. The other thing is, is the drug toxic to the kidneys? So that giving it will actually, in some patients do the opposite, give them a worse renal function...
I think for renal impairment, you have to have several thoughts in your head at the same time. One is that the higher the efficacy of the drug is, the faster the situation in the patient gets better with lower light chains, which makes it possible to increase renal function if that was caused by myeloma. The other thing is, is the drug toxic to the kidneys? So that giving it will actually, in some patients do the opposite, give them a worse renal function. And then there are, of course, that renal function sometimes forces you to choose different doses. And for this reason, I think for every drug, it’s important to show that it’s safe in renal failure patients, that the renal failure in a fraction of the patients improves, and how this is over several trials, and also comparison with other regimens. So pomalidomide, len, dex which was the control in the study, which is maybe the biggest part of this analysis, is a drug where we do not think it affects renal function, so you can give it in normal doses. Melflufen, this has been a newer drug, so we didn’t know all about that. So this analysis is taking all the studies with melflufen to see how it affects renal function. And sort of as we expected, we would need to show it, is that it does not hamper renal function. It improves a little bit through the treatment. Actually, there’s a trend to a better renal function compared to pomalidomide in the randomized trial so this is just a part of a drug’s pathway where you need to also show this because the renal patients are important and I think when it comes to what do you do with patients with renal impairment, you have to separate between those you believe have a renal failure because of myeloma and they have a treatment need. And it’s important to treat as good as possible. Do not wait to give efficacious drugs. You need to get in there early and reduce the tumor load to improve the renal function. The other thing is patients who have a renal failure because of some other disease, hypertension or many other reasons, diabetes for renal dysfunction. And if those patients do not have such a big tumor load, you don’t think the myeloma affects the kidneys. And it’s more important to not overdose the patients, especially with drugs that are renally eliminated, which are some of the drugs.
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