Explaining the FDA’s approval of Breyanzi for lymphoma

Jun 29, 2022
Devin Golden

Last week, the U.S. Food and Drug Administration (FDA) approved Breyanzi® for earlier use to treat many types of non-Hodgkin lymphoma. It was a historic moment, as Breyanzi became just the second cancer cell and gene therapy approved for use after only one other type of treatment has failed.

Breyanzi (brand name for lisocabtagene maraleucel) is a CD19-focused CAR T-cell therapy. This means Breyanzi is an engineered T-cell therapy that looks for cells with the CD19 protein. This protein is common on most forms of non-Hodgkin lymphoma cells. CAR stands for “chimeric antigen receptor,” which is a laboratory-created protein receptor added to T cells to re-train them to look for these cancer-related proteins.

Breyanzi originally was approved for certain types of non-Hodgkin lymphoma after patients tried two other treatments. Now, many patients don’t have to wait as long to receive CAR T cells that have led to remarkable survival times in blood cancer patients.

Why did the FDA make Breyanzi available to patients sooner? What does this mean for patients? And how does the FDA’s approval compare to the one they granted Yescarta® a few months ago?

Specifics of Breyanzi’s new FDA approval

Yescarta (axicabtagene ciloleucel) was the first CAR T-cell therapy approved as a second-line option for many non-Hodgkin lymphoma patients. This approval came in April of 2022.

However, Breyanzi’s approval may help a larger number of patients.

The FDA approved Breyanzi for certain types of non-Hodgkin lymphoma if chemotherapy does not work. The wording in the approval states Breyanzi is now available to patients with cancers resistant to first-line chemotherapy or cancers that relapse within 12 months after trying chemotherapy.

Breyanzi is also approved for patients “not eligible for a stem-cell transplant due to comorbidities or age.” If a patient relapses outside of the first 12 months after chemotherapy, they’d usually either receive a stem-cell transplant or try chemotherapy again. 

Now, if a patient relapses more than a year after receiving immunotherapy and can’t have a stem-cell transplant, they can move to the CAR T-cell therapy Breyanzi. They don’t need to try chemotherapy again.

Approximately 80,000 people in the United States are diagnosed each year with non-Hodgkin lymphoma. According to the press release from Bristol Myers Squibb, the manufacturer of Breyanzi, close to 40% of patients with non-Hodgkin lymphoma do not benefit from chemotherapy. A significant portion of those patients are not eligible for a stem-cell transplant.

Therefore, tens of thousands of people who did not respond to chemotherapy initially could only try a stronger regimen of chemotherapy again. Many of those patients now have a new option in Breyanzi.

Examining survival of Breyanzi for non-Hodgkin lymphoma

This latest FDA approval is based on results of a phase 3 clinical trial using Breyanzi for non-Hodgkin lymphoma. The study showed the benefit of using this CAR T-cell therapy earlier.

In the study, Breyanzi had a median event-free survival (no growth of tumors) of 10 months. Standard of care (chemotherapy followed by a stem-cell transplant) had an event-free survival of 2.3 months.

Breyanzi also led to a complete response (no signs of cancer on scans) in 66% of patients. Standard of care only worked this effectively for 39% of patients.

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