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Zynlonta FDA Approval History

Last updated by Judith Stewart, BPharm on May 2, 2021.

FDA Approved: Yes (First approved April 23, 2021)
Brand name: Zynlonta
Generic name: loncastuximab tesirine-lpyl
Dosage form: Injection
Company: ADC Therapeutics SA
Treatment for: Diffuse Large B-cell Lymphoma

Zynlonta (loncastuximab tesirine-lpyl) is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

  • Zynlonta is administered via intravenous infusion over 30 minutes on Day 1 of each cycle (every 3 weeks). Oral or IV dexamethasone is recommended as a premedication twice daily for 3 days starting the day before treatment to minimize the chance of side effects.
  • Zynlonta may cause serious side effects including fluid retention, low blood cell counts, infections, and skin reactions. Common side effects include thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

Development Timeline for Zynlonta

DateArticle
Apr 23, 2021Approval  FDA Approves Zynlonta (loncastuximab tesirine-lpyl) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sep 24, 2020ADC Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

Further information

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