FDA Approves ZYNLONTA for the Treatment of Adult Patients with Elapsed or Refractory Large B-Cell Lymphoma after Two or More Lines of Systemic Therapy
On April 23, 2021, the FDA approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with 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. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
ZYNLONTA is administered as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks). The approved recommended dosage of ZYNLONTA is 0.15 mg/kg every 3 weeks for 2 cycles, then 0.075 mg/kg every 3 weeks for subsequent cycles. Patients should be premedicated with dexamethasone 4 mg orally or IV twice daily for 3 days beginning the day before administering ZYNLONTA. If dexamethasone administration does not start the day before ZYNLONTA, begin at least 2 hours prior to administration of ZYNLONTA.
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On February 9, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms....