FDA approves Zynlonta for relapsed or refractory diffuse large B-cell lymphoma
The FDA granted accelerated approval to loncastuximab tesirine-lpyl for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, according to the agent’s manufacturer.
The approval applies to use of the agent by patients who received at least two lines of prior systemic therapy.
Loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics) is a CD19-targeted antibody-drug conjugate.
The FDA based the approval on results of the single-arm, phase 2 LOTIS-2 trial, which included 145 patients with relapsed or refractory DLBCL who received two or more lines of systemic therapy.
Researchers reported a 48.3% overall response rate, a 24.1% complete response rate and a 24.1% partial response rate. Median time to response was 1.3 months, and median duration of response was 10.3 months.
The most common grade 3 or higher treatment-emergent adverse events in LOTIS-2 included neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increase (17.2%) and anemia (10.3%).
“There is a significant unmet need for treatment options for patients with [relapsed or refractory] DLBCL, including those who have been heavily pretreated and have difficult-to-treat disease,” Paolo F. Caimi, MD, associate professor in the department of medicine and member of the hematopoietic and immune cancer biology program at Case Comprehensive Cancer Center, said in an ADC Therapeutics-issued press release. “Single-agent Zynlonta demonstrated clinically important outcomes in the pivotal LOTIS-2 study across several disease subtypes. Notably, this included transplant-eligible and -ineligible patients, and patients who previously received stem cell transplant or [chimeric antigen receptor T-cell therapy].”
Read more about