IOVA Iovance

lifileucel · NCT06743126 registry update

completion: 2031-10 → 2032-08-12; enrollment: 360 → 450

lifileucel · NCT07741877 registry update

status: NOT_YET_RECRUITING → RECRUITING; countries: {'total_sites': 0, 'us_sites': 0} → {'total_sites': 2, 'us_sites': 2}

lifileucel · NCT07288203 registry update

primary_completion: 2032-12 → 2027-12; completion: 2033-12 → 2028-06; enrollment: 100 → 24

lifileucel · NCT05727904 registry update

countries: {'total_sites': 81, 'us_sites': 24} → {'total_sites': 82, 'us_sites': 24}

Iovance: FDA Fast Track Designation for lifileucel in Soft Tissue Sarcomas

The FDA granted Fast Track Designation to lifileucel for undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS) based on early ORR data from the SARATOGA registrational trial. This designation provides expedited regulatory interactions and potential rolling review for this new indication. The company also reported record 2Q26 Amtagvi revenue of ~$99M and confirmed ongoing global expansion plans.

Iovance receives FDA Fast Track for lifileucel in 2L+ advanced NSCLC

The U.S. FDA granted Fast Track Designation to lifileucel for previously treated metastatic nonsquamous NSCLC. This designation provides a regulatory pathway for expedited development and review, supporting the registrational IOV-LUN-202 trial and a potential supplemental BLA for accelerated approval with a targeted launch in the second half of 2027.

Iovance reports 26% ORR, mDOR not reached for lifileucel in NSCLC

The IOV-LUN-202 trial interim data show a 26% objective response rate and median duration of response not reached after >25 months follow-up in previously treated advanced nonsquamous NSCLC. FDA has already provided positive feedback on the trial design and potency assay matrix; the company expects trial completion in 2026 to support a supplemental BLA with potential launch in 2027.