ZYNLONTA (loncastuximab tesirine-lpyl) — Regulatory decision
this year
The Company is also evaluating a regulatory pathway for this combination and plans to submit for Breakthrough Therapy designation (BTD) this year.Source filing
ADCT biotech catalysts & pipeline
ADC THERAPEUTICS SA · Data as of 2026-09-08
Upcoming catalysts
ZYNLONTA (loncastuximab tesirine-lpyl) — Full data
Late 2026
In addition, the Company continues to advance the ZYNLONTA franchise through the ongoing Phase 1b LOTIS-7 trial evaluating ZYNLONTA in combination with glofitamab in 2L+ DLBCL, with data anticipated by the end of 2026, as well as through support for Phase 2 IITs exploring ZYNLONTA across indolent lymphomas.Source filing
ZYNLONTA (loncastuximab tesirine-lpyl) — NDA/BLA submission
Q4 2026
ADC Therapeutics expects to submit an sBLA in the fourth quarter of 2026.Source filing
ZYNLONTA (loncastuximab tesirine-lpyl) — Regulatory decision
mid-2027
Assuming positive results, a supplemental Biologics License Application (sBLA) submission to the U.S. FDA will follow, with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ DLBCL in mid-2027.Source filing
ZYNLONTA (loncastuximab tesirine-lpyl) — Conference presentation
2026
We look forward to the presentation of the LOTIS-5, LOTIS-7 and MZL investigator-initiated trial data later this year and expect submission for publication.Source filing
ZYNLONTA (loncastuximab tesirine-lpyl) — Conference presentation
Dec 12–Dec 15
Full LOTIS-5 data submitted to ASH for presentation in Q4 2026Source filing
ZYNLONTA (loncastuximab tesirine-lpyl) — Conference presentation
Q2 2027
The Company also anticipates presentation of updated FL data in Q2 2027.Source filing