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Find out which drugs or clinical trials are on hold or have been withdrawn from use.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.
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Find out which drugs or clinical trials are on hold or have been withdrawn from use.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.
FEATURE
Zanubrutinib Approved in the U.S. for Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL)
With the FDA’s approval of zanubrutinib, CLL/SLL patients have another very strong choice to manage their disease.
Zanubrutinib is the third Bruton’s Tyrosine Kinase or BTK inhibitor (BTKi) to be approved by the FDA, following ibrutinib and acalabrutinib. They all work similarly by irreversibly binding to BTK and thus blocking B-cell receptor (BCR) signaling in the cancer cells. Since CLL/SLL cells are addicted to this pathway, blocking BCR stops the cancer in its tracks.
FDA Announces Evusheld is Not Currently Authorized for Emergency Use in the U.S.
As of 1/26/23, Evusheld (tixagevimab co-packaged with cilgavimab) is no longer available as Pre-Exposure Prophylaxis (PrEP) in the United States. That decision was made because as the virus continued to mutate, now over 90% of SARS-CoV-2 variants of concerns (VOC) circulating in the U.S. are no longer believed to be neutralized by the monoclonal antibody (mAb) cocktail.
ADDITIONAL READING
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.
