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The World’s Leading Authority for Chronic Lymphocytic Leukemia Patients

Regulatory News

All those whose lives are touched by CLL are affected by the pharmaceutical industry, insurance coverage, and government regulations. Which medications are available for which indications, where new ones are in the approval process, what they cost, who can access them, and what resources are available to help with equitable access, are controlled by the FDA, the CDC, federal and state authorities, the drug manufacturers, as well as insurance providers, including Medicare and Medicaid. CLL Society keeps you up to date on that news in this section.

4 Action Steps to Take Right Now

Step One

Start by researching which medications you think you might need on your CLL / SLL journey, then checking to see if they are part of your insurance plan’s formulary. Lists of covered medications are often published by insurance plans. You can also call the insurance company’s helpline or even your pharmacy. Find out if it is possible to access drugs that are not on the formulary or consider participating in plans that do offer coverage for the medications you need.

Step Two

Learn as much as you can about those new drugs that might be helpful in your circumstances, then monitor their progress as they come close to FDA approval by following CLL Society’s clinical trial and regulatory news.

Step Three

Find out which drugs or clinical trials are on hold or have been withdrawn from use.

Step Four

Be aware of how legislation and government policies can affect affordable and equitable access to necessary treatments. CLL Society works hard on your behalf to bring about improved availability and controlled costs for the community we serve.

Please consider helping CLL Society in its advocacy work.

Step One

Start by researching which medications you think you might need on your CLL / SLL journey, then checking to see if they are part of your insurance plan’s formulary. Lists of covered medications are often published by insurance plans. You can also call the insurance company’s helpline or even your pharmacy. Find out if it is possible to access drugs that are not on the formulary or consider participating in plans that do offer coverage for the medications you need.

Step Two

Learn as much as you can about those new drugs that might be helpful in your circumstances, then monitor their progress as they come close to FDA approval by following CLL Society’s clinical trial and regulatory news.

Step Three

Find out which drugs or clinical trials are on hold or have been withdrawn from use.

Step Four

Be aware of how legislation and government policies can affect affordable and equitable access to necessary treatments. CLL Society works hard on your behalf to bring about improved availability and controlled costs for the community we serve.

Please consider helping CLL Society in its advocacy work.

FEATURE

Pirtobrutinib is the First Reversible BTKi Approved in CLL / SLL

On Dec. 1, 2023, pirtobrutinib received accelerated approval from the FDA for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients who had failed two prior lines of therapy, including a BTK inhibitor (BTKi) and a BCL-2 inhibitor.

This approval was based on the BRUIN trial results, where the overall response rate was 72%, and the median duration of response was a little over a year. All responses were partial responses.

These are outstanding results in a difficult-to-treat population who now have an excellent approved option when their choices were limited before.

Read more.

ADDITIONAL READING

CLL Society - CLL Information and Management
RECENT NEWS

When appropriate, the CLL Society will be posting updates and background information on the present Coronavirus pandemic focusing on reliable primary sources of information and avoiding most of the news that is not directly from reliable medical experts or government and world health agencies.