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Will Venetoclax Be Approved for Patients With the 11q Deletion?

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Published on September 13, 2016

Is there a chance that venetoclax can be used for patients with 11q deletion? In this Ask the Expert segment, Dr. Nicole Lamanna of Columbia University Medical Center, answers this viewer's question. Currently approved for patients with the 17p deletion, Dr. Lamanna reports that a broader approval for venetoclax (Venclexta) is coming.  Listen as Dr. Lamanna explains why she is pleased that it is being selectively rolled out.

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Transcript | Will Venetoclax Be Approved for Patients With the 11q Deletion?

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you. 

Andrew Schorr:

Patient writes, I was delighted to hear that venetoclax (Venclexta) has been approved by the FDA in the U.S. and disappointed that it was not also approved for patients with 11q deletion that underwent prior therapy.  As we know, it was approved for people with the 17p deletion.  Is there any chance the venetoclax could be used for patients with 11q?  

Dr. Lamanna:

Yeah, it's coming. You know, we perceive that obviously—we have lots of data that venetoclax is active in relapsed patients, whether it's 17p or 11q or otherwise.  So the data is there.  It's just going to take a little time for it to actually get approved probably in relapsed for all patients with CLL. 

Obviously, there are still clinical trials running with venetoclax, so depending upon your location—I don't know where this person is—you might be eligible for a clinical trial that has venetoclax.  There [are] obviously even new clinical trials combining venetoclax with other agents as well, so stay tuned.  But certainly that might be an option.  Right now, no, so obviously with—outside the context of a clinical trial the likelihood is that you won't probably get coverage insurance?wise for venetoclax off of a clinical trial. However, that being said, it's certainly—the likelihood is it will get approved soon for relapsed patients in general, so just stay tuned and wait. 

But I have to say I think it's going to be—in some respects I'm a little happy it's being rolled out selectively, because one of the concerns about this new agent, of course, is a side effect called tumor lysis syndrome, where the leukemia cells die very quickly, which is great. But the doctors have to watch for these electrolyte abnormalities. And for those who haven't given this new agent who might be in the community, it's going to take a learning curve. And so in some ways I think it's good, because it will be done slower in the community as it rolls out for doctors who aren't used to giving this agent, and perhaps then we can see that there will be less complications.  And that's a concern of mine that I have for those who don't know how to use the drug. 

Andrew Schorr:

Safety first. 

Dr. Lamanna:

Safety first. 

Please remember the opinions expressed on Patient Power are not necessarily the views of our sponsors, contributors, partners or Patient Power. Our discussions are not a substitute for seeking medical advice or care from your own doctor. That’s how you’ll get care that’s most appropriate for you. 

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