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FDA Approves Zynlonta for Diffuse Large B-Cell Lymphoma

FDA Approves Zynlonta for Diffuse Large B-Cell Lymphoma
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Published on April 30, 2021

New Treatment for DLBCL Receives FDA Approval

Patients with diffuse large b-cell lymphoma (DLBCL) have a new treatment option to consider. On April 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta) for the treatment of relapsed/refractory DLBCL in adults who have received at least two prior therapies.

“This is a great time for research and drug development for patients with DLBCL,” Jason Westin, MD, the Director of Lymphoma Clinical Research at MD Anderson Cancer Center told Patient Power.

“The approval of [Zynlonta] provides us with another potent weapon and will expand our ability to improve the lives of our patients. With multiple options for therapy available, our challenge now is to identify which patient should receive which drug, and to identify combinations which can increase our ability to cure DLBCL,” added Dr. Westin, who was not involved in the study of Zynlonta.

About the LOTIS-2 Study

The FDA based its approval of Zynlonta, a CD19-targeted antibody-drug conjugate, on data from the LOTIS-2 study, a single-arm trial of 145 adult patients with relapsed or refractory DLBCL or high-grade B-cell lymphoma following two or more lines of prior therapy. An antibody-drug conjugate, which is often used in cancer, is a targeted therapy that brings together a drug and monoclonal antibody.

Study participants received 30-minute intravenous infusions of Zynlonta at a dose of 0.15 mg/kg once every three weeks for two cycles, then 0.075 mg/kg once every three weeks for subsequent cycles up to one year, or until disease progression or unacceptable toxicity.

The overall response rate (ORR) was 48.3%, with a complete response rate (CRR) of 24.1% and a partial response rate (PRR) of 24.1%. The median response duration for the 70 patients who responded to treatment was 10.3 months.

The most common side effects reported during LOTIS-2 were neutropenia (low white blood cell count), thrombocytopenia (low blood platelet count), increased levels of gamma-glutamyl transferase (an enzyme commonly found in the liver), and anemia.

Treatment Options for DLBCL

DLBCL is the most common type of non-Hodgkin lymphoma (NHL) in the United States, with more than 18,000 people diagnosed each year, according to the Lymphoma Research Foundation. It is a fast-growing lymphoma that affects the B-lymphocytes (a type of white blood cell), and it can be difficult to treat.

But clinical trials are leading to expanded treatment options for patients with large B-cell lymphoma. The approval of Zynlonta comes on the heels of the Feb. 5, 2021, FDA approval of lisocabtagene maraleucel (Breyanzi), a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adults with large B-cell lymphoma who have not responded to or have relapsed after two previous treatments. There are two other CAR T-cell therapies also approved for DLBCL. 

Zynlonta is manufactured by ADC Therapeutics and will soon be available in the United States. For more information, talk to a lymphoma specialist.

~Suzanne Mooney

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