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We Need Your Help: The FDA Will Be Reviewing Whether Duvelisib Should Be Withdrawn or Continue to be Approved for Relapsed/Refractory CLL

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  • CLL Society would like to make a special request to all of those who have CLL / SLL in our community to please consider submitting a personal comment to the FDA regarding the possibility of duvelisib being removed as an available treatment option. It doesn’t matter if you have or have not been on duvelisib before! As a patient, you can talk about the sincere need to have further treatment options available to you in the future should the only other two FDA-approved drug classes fail you.

A letter was penned in June to the FDA that received signatures of support from many of the country’s top CLL / SLL physicians. Since then, we have been advised that if the FDA hears from multiple patients on this issue, there may be a higher chance of significantly moving the needle.

We realize that many have not yet had to take a PI3K inhibitor such as duvelisib. However, CLL Society also understands that patients who run out of therapy options when their disease progresses after being on both a BTK and a BCL-2 inhibitor have a dismal prognosis. Therefore, continuing to have PI3K inhibitors as a remaining FDA-approved treatment option is extremely important.  

There are risks involved with any drug, and we do not want to downplay the potential toxicities associated with PI3K inhibitors. We also acknowledge that duvelisib is far from being a perfect medication. However, we disagree with the FDA’S conclusions. We believe that the decision to take duvelisib should be a continued available treatment option as part of the shared decision-making process between a patient and their healthcare provider as to whether it is an appropriate choice.

In addition, removing PI3K inhibitors from the market is incredibly important to the CLL / SLL community because it already has a chilling effect on future CLL / SLL drug development.

On September 23, 2022, the Oncologic Drug Advisory Committee (ODAC) will review the drug’s previous approved use “for treating adult patients with relapsed or refractory CLL / SLL after having been on at least two prior therapies.” September 8th is the date that really matters, as this is the deadline to submit your personal comments to be reviewed by ODAC.

There are very detailed instructions on how to submit comments to ODAC located here. However, here are some simplified key highlights taken from the detailed instructions:

  • You can submit your comments electronically through this link.
  • From the dropdown menu titled “What is Your Comment About” choose the category named “Drug Industry – C002” as your selection.
  • All electronically submitted comments will be posted to the docket unchanged exactly as you typed them in and will be made public. So, you are solely responsible for ensuring that your comment does not include any confidential information you do not want to be made available to the public (such as your name, contact information, identifiable medical information, Social Security numbers, or other confidential information). It is at your discretion what you choose to share.
  • If you would like to submit your comment anonymously, select the box at the very bottom which says “anonymous”. Then the only information you will be required to submit is your email address (which will not be shared with the general public).
  • If you have any questions, please contact us via [email protected].

If you know any other individuals who would be willing to submit a comment to the ODAC committee on this subject, please feel free to ask them and share the instructions as well.

Thank you so much for joining this vital advocacy effort on behalf of all CLL / SLL patients. We cannot do this without you!

Stay strong. We are all in this together.

Brian Koffman, MDCM (retired), MS Ed
Co-Founder, Executive VP, and Chief Medical Officer
CLL Society, Inc.