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What CLL Drug Approvals Are Underway?

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Published on August 9, 2019

Are there more tools being developed to treat chronic lymphocytic leukemia (CLL)? At a recent town meeting in Portland, leading expert Dr. Jeff Sharman discussed a new therapy that is predicted to gain FDA approval for relapsed CLL patients towards the end of 2019. Watch now to learn more about CLL targeted therapy options.

This town meeting is sponsored by Pharmacyclics LLC and Janssen Biotech, Inc. It is produced by Patient Power in partnership with The CLL Global Research Foundation, The US Oncology Network, Compass Oncology, Willamette Valley Cancer Institute and Research Center, and The Leukemia & Lymphoma Society (LLS).

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I am a newly diagnosed CLL/SLL patient, at the age of 48, with 3 young children.Th e diagnosis was difficult to swallow, but I am dealing with it much better now. I am very thankful for your website. I find the information excellent (and I am a pharmacist so I am critical of the information I get), and the website gives me so much hope. My sister who lives in France (I am in the US) also appreciates your website, so she can learn more about my condition, and she too needs hope for all of us. You have been a light in my tunnel. As I get out of this tunnel, I will continue to rely on your website for both knowledge and hope. I am so grateful for the work that you all do. You are truly a blessing.

— Sincerely, Ann

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The Leukemia & Lymphoma Society (LLS) CLL Global Research Foundation The US Oncology Network Willamette Valley Cancer Institute and Research Center

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Transcript | What CLL Drug Approvals Are Underway?

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.

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:          

So, venetoclax (Venclexta) now has been approved also first line with an infused monoclonal antibody, obinutuzumab, or Gazyva. So, that’s new. Like, even from just a few days ago. 

Dr. Sharman:              

Wednesday.  

Andrew Schorr:          

This is Saturday. 

Dr. Sharman:              

Yeah. 

 

Andrew Schorr:          

So, the idea is you have more tools. Then under ibrutinib (Imbruvica), we see acalabrutinib, same class. Calquence is the trade name. That’s approved for mantle cell lymphoma, and the question will be does the FDA approve it for CLL.  

Dr. Sharman:                 

So, a couple things—access to drugs is oftentimes predicated on what’s approved. So, if it’s approved, insurance companies have to cover it, but there are also guideline panels, the most prominent out there being what’s called the NCCN. If NCCN guidelines endorse the medication under specific circumstances, often there too insurance companies will pay for it.  

So, currently, Calquence is not approved in CLL. However, I probably have maybe a dozen or two dozen patients I take care of with CLL on it because the NCCN guidelines endorse it under specific circumstances. It is not approved. 

However, we have a press release already out that they had to close the study early because it met its end points. Calquence will be approved presumably soon in relapsed CLL and I am leading the study to get it approved in the frontline setting. So, we should be hearing some news about that towards the end of this year. 

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.