The U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adults with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy.
The approval was announced in a news release issued by the agency.
The effectiveness of the drug was determined in the TRANSCEND FL-MZL Cohort, an open-label, multicenter, single-arm trial of adults with relapsed or refractory marginal zone lymphoma who had received at least two or more prior lines of systemic therapy or who had experienced disease relapse after having undergone hematopoietic stem cell transplant. The trial included patients with an ECOG performance status of 1 or less, according to the agency.
In the trial, patients received a single dose of Breyanzi two to seven days after the completion of lymphodepleting chemotherapy, with the efficacy analyses performed in 77 leukapheresed patients and in 66 patients who had confirmed measurable disease by CT scan at baseline, received conforming product in the intended dose range and had at least nine months of follow-up from the date of first-response.
The overall response rate in the intention-to-treat-population was 84.4% and the complete response rate was 55.8%. The median duration of response was not reached.
Glossary
ECOG performance status: a scale doctors use to describe how well a person with cancer is able to carry out everyday activities.
Leukapheresed: a procedure where white blood cells are removed from the blood. The blood is taken out, the needed cells are separated and the rest is returned to the body.
Overall response rate: the percentage of patients whose cancer shrinks or disappears after a treatment.
Complete response rate: the percentage of patients whose cancer becomes undetectable after treatment.
Cytokine release syndrome (CRS): a reaction that can happen when the immune system becomes very active during some treatments. It can cause fever, tiredness, and low blood pressure.
Hypersensitivity reactions: allergic-type reactions some people may have to medicines. Symptoms can range from mild (rash, itching) to more serious (trouble breathing).
Cytopenias: a lower-than-normal number of blood cells. This can include red blood cells (anemia), white blood cells (neutropenia) or platelets (thrombocytopenia).
Hypogammaglobulinemia: a condition where the body has lower levels of immunoglobulins (antibodies). This can make it harder to fight infections.
Immune effector cell–associated hemophagocytic lymphohistiocytosis–like syndrome (IEC-HLH–like syndrome): a rare but serious immune system reaction that can happen with some cell-based cancer therapies. The immune system becomes overly active and causes inflammation throughout the body.
According to the FDA, the prescribing information for Breyanzi includes warnings and precautions for cytokine release syndrome (CRS), neurologic toxicities, hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies and immune effector-cell-associated hemophagocytic lymphohistiocytosis-like syndrome.
How Does Breyanzi Work?
A type of cellular immunotherapy known as CAR-T cell therapy, Breyanzi is made using a patient’s own T cells, a type of immune system cell, as explained by the National Cancer Institute on its website. A gene for a special receptor called chimeric antigen receptor (CAR) is added to the T cells in the laboratory, and these changed T cells, called CAR-T cells, are grown in large numbers in the laboratory and given to the patient by infusion. Breyanzi binds to a protein called CD19, which is found on most B-cell lymphoma cells. This helps the body’s immune system kill cancer cells, the National Cancer Institute explained.
Breyanzi, the National Cancer Institute stated, is also used for adults with chronic lymphocytic leukemia, small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, or certain types of large B-cell lymphoma that relapsed or did not get better after treatment with at least one or two lines of systemic therapy.
It was announced in August that the FDA had accepted a supplemental biologics license application (sBLA) for Breyanzi as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy, according to a news release from manufacturer Bristol Myers Squibb.
“While initial therapy for marginal zone lymphoma can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates,” Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb, said in the news release issued at the time. “This FDA acceptance brings us one step closer to potentially standardizing CAR-T cell therapy as a treatment option for marginal zone lymphoma, while building on our commitment to bring this personalized therapy to as many eligible patients as possible.”
References
- “FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma,” FDA; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
- “Breyanzi,” National Cancer Institue; https://www.cancer.gov/publications/dictionaries/cancer-terms/def/breyanzi
- “FDA Accepts Breyanzi sBLA for Relapsed Marginal Zone Lymphoma,” https://www.curetoday.com/view/fda-accepts-breyanzi-sbla-for-relapsed-marginal-zone-lymphoma
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