Amtagvi (lifileucel) — Topline data
2026
• Completion of enrollment and data update expected in 2026 with potential launch in 2H27Source filing
IOVA biotech catalysts & pipeline
IOVANCE BIOTHERAPEUTICS INC · Data as of 2026-09-08
Upcoming catalysts
Amtagvi (lifileucel) — Regulatory decision
2026
The MAA for Amtagvi in the UK was resubmitted in early July and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency (MHRA) for potential approval later in 2026.Source filing
IOV-5001 — IND submission
2026
An IND application submission is currently planned for 2026.Source filing
Amtagvi (lifileucel) — Topline data
4Q26
Enrollment is nearly complete in the pivotal cohorts and program updates are expected in 4Q26.Source filing
Amtagvi (lifileucel) — Initial data
1H27
Multiple patients have been treated for cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) with initial data expected in 1H27.Source filing
Amtagvi (lifileucel) — Regulatory decision
1H27
Potential approval of the MAA in Switzerland is expected in 1H27, opening a second market opportunity in Europe with the potential for medical tourism.Source filing
Amtagvi (lifileucel) — NDA/BLA submission
2027
An MAA resubmission for Amtagvi in advanced melanoma to the European Medicines Agency is on track for 2027.Source filing
Amtagvi (lifileucel) — NDA/BLA submission
H2 2027
Support a supplemental Biologics License Application for U.S. accelerated approval with a potential launch in the second half of 2027.Source filing
Amtagvi (lifileucel) — Conference presentation
Oct 23–Oct 27
Results will be highlighted in an oral presentation (abstract #3725RO) at the European Society for Medical Oncology (ESMO) meeting in Madrid, Spain, from October 23–27, 2026.Source filing