🇺🇸 TEBENTAFUSP in United States

FDA authorised TEBENTAFUSP on 29 November 2022 · 152 US adverse-event reports

Marketing authorisation

FDA — authorised 29 November 2022

  • Application: BLA761228
  • Marketing authorisation holder: IMMUNOCORE LTD
  • Indication: Labeling
  • Status: approved

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. Cytokine Release Syndrome — 42 reports (27.63%)
  2. Pyrexia — 22 reports (14.47%)
  3. Malignant Neoplasm Progression — 19 reports (12.5%)
  4. Disease Progression — 13 reports (8.55%)
  5. Rash — 11 reports (7.24%)
  6. Chills — 10 reports (6.58%)
  7. Hypotension — 10 reports (6.58%)
  8. Pruritus — 10 reports (6.58%)
  9. Vomiting — 8 reports (5.26%)
  10. Death — 7 reports (4.61%)

Source database →

TEBENTAFUSP in other countries

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

Frequently asked questions

Is TEBENTAFUSP approved in United States?

Yes. FDA authorised it on 29 November 2022.

Who is the marketing authorisation holder for TEBENTAFUSP in United States?

IMMUNOCORE LTD holds the US marketing authorisation.