FDA grants priority review to loncastuximab tesirine for advanced DLBCL
The FDA granted priority review to loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma, according to the agent’s manufacturer.
Loncastuximab tesirine (Lonca, ADC Therapeutics) — an antibody-drug conjugate — is composed of a humanized monoclonal antibody directed against CD19 and conjugated through a linker to a pyrrolobenzodiazepine dimer cytotoxin.
A phase 2 trial evaluated loncastuximab tesirine for 145 patients with relapsed or refractory DLBCL who received at least two prior lines of therapy. Results showed a 48.3% overall response rate — exceeding the threshold established for the study to meet its primary endpoint — and a 24.1% complete response rate.
The agent exhibited a manageable tolerability profile, according to investigators. The most common grade 3 or higher treatment-emergent adverse events included neutropenia (25.5%), thrombocytopenia (17.9%), increased gamma-glutamyltransferase (16.6%) and anemia (10.3%).
The FDA is expected to make a decision on approval for this indication by May 21.
“The FDA’s acceptance of our biologics license application and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021,” Chris Martin, DPhil, CEO of ADC Therapeutics, said in a company-issued press release.
Loncastuximab tesirine is being investigated in a phase 1/phase 2 trial in combination with ibrutinib (Imbruvica; Pharmacyclics, Janssen) for patients with relapsed or refractory DLBCL or mantle cell lymphoma, as well as in a phase 3 trial in combination with rituximab (Rituxan; Genentech, Biogen) for treatment of patients with relapsed or refractory DLBCL.
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