🇺🇸 LONCASTUXIMAB TESIRINE in United States

FDA authorised LONCASTUXIMAB TESIRINE on 20 February 2026 · 78 US adverse-event reports

Marketing authorisation

FDA — authorised 20 February 2026

  • Application: BLA761196
  • Marketing authorisation holder: ADC Therapeutics SA
  • Indication: Labeling
  • Status: approved

The FDA approved LONCASTUXIMAB TESIRINE, a monoclonal antibody-drug conjugate, for its approved indication. The approval was granted to ADC Therapeutics SA, the marketing authorisation holder. The application was submitted under the standard expedited pathway.

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Disease Progression — 17 reports (21.79%)
  2. Pneumonia — 9 reports (11.54%)
  3. Thrombocytopenia — 8 reports (10.26%)
  4. Anaemia — 7 reports (8.97%)
  5. Platelet Count Decreased — 7 reports (8.97%)
  6. Cns Ventriculitis — 6 reports (7.69%)
  7. Covid-19 — 6 reports (7.69%)
  8. Death — 6 reports (7.69%)
  9. Drug Ineffective — 6 reports (7.69%)
  10. Gamma-Glutamyltransferase Increased — 6 reports (7.69%)

Source database →

LONCASTUXIMAB TESIRINE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is LONCASTUXIMAB TESIRINE approved in United States?

Yes. FDA authorised it on 20 February 2026.

Who is the marketing authorisation holder for LONCASTUXIMAB TESIRINE in United States?

ADC Therapeutics SA holds the US marketing authorisation.