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Find out which drugs or clinical trials are on hold or have been withdrawn from use.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

FDA Places Partial Clinical Hold on Studies Featuring Umbralisib and Ublituximab in CLL and Non-Hodgkin Lymphoma

The FDA has placed a partial hold on clinical trials using umbralisib plus ublituximab, often abbreviated to U2, in CLL and other lymphomas due to a possible increased mortality risk.

The combination of umbralisib plus ublituximab has promising activity in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) as shown in this ASH 2021 abstract: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 Unity-CLL Study.

That study showed that U2 significantly prolonged progression-free survival (PFS) compared to Obinutuzumab plus Chlorambucil (O+Chl) (median 31.9 months vs 17.9 months), but PFS is not the whole story. Read more.

ADDITIONAL READING

TG Therapeutics, after a decade of development, is withdrawing its application for the combination of ublituximab and UKONIQ (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).