Iovance Biotherapeutics Pushes FDA Rolling Submission Deadline Into Next Year For Its Lead Skin Cancer Candidate

Iovance Biotherapeutics Pushes FDA Rolling Submission Deadline Into Next Year For Its Lead Skin Cancer Candidate
  • Iovance Biotherapeutics Inc IOVA announced that its ongoing rolling Biologics License Application (BLA) submission to the FDA for lifileucel is expected to be completed in the first quarter of 2023 as against Q4 FY22 expected earlier.
  • As part of an amendment to the ongoing investigational new drug application submitted during Q3, Iovance received recent FDA feedback regarding supplemental assay validation information and comparability data for lifileucel. 
  • Iovance will address these FDA comments and complete its rolling BLA submission in the first quarter of 2023.
  • The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced melanoma. 
  • The Phase 3 trial of lifileucel, in combination with pembrolizumab in frontline advanced melanoma, is on track to begin in late 2022, is intended to serve as a confirmatory study and is expected to be well underway at the time of a potential approval. 
  • Updated data from the combination cohort of lifileucel and pembrolizumab in immune checkpoint inhibitor naïve patients demonstrated an overall response rate of 67%
  • Price Action: IOVA shares are down 8.94 at $6.47 on the last check Friday.

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