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April 26, 2021Zynlonta Approved to Treat Large B-Cell Lymphoma
April 23, 2021 – The U.S. FDA has approved ZynlontaTM (loncastuximab tesirine-lpyl), manufactured by ADC Therapeutics, to treat adults who have relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
DLBCL is the most common form of non-Hodgkin lymphoma diagnosed in the United States. It is an aggressive cancer, though it can be cured in approximately half of all patients. The chances of a good prognosis are higher in patients whose disease is identified at an early stage. Later stage disease and disease that has returned or progressed following treatment have lower survival rates.
In a clinical study, Zynlonta demonstrated a 48.3% overall response rate, 1.3-month median time to response, and 10.3-month median duration of response. Recommended dosing is 0.15mg/kg of the patient’s body weight once every three weeks for the first two doses, then 0.075mg/kg of body weight once every three weeks thereafter. Zynlonta is administered via 30-minute intravenous infusion.
The drug has launched at a wholesale acquisition cost (WAC) of $23,500 per 10mg vial.