Iovance Biotherapeutics Receives FDA Agreement for Expedited Review of Lifileucel Drug
- Wednesday, October 16, 2024
Shares of Iovance Biotherapeutics saw a boost after the company announced that the Food and Drug Administration (FDA) has agreed to expedite the remaining review of its lifileucel drug, despite the agency's resource constraints.
Stock Surge
Iovance stock experienced an 11% increase in premarket trading, reaching $5.16. Year-to-date, however, the stock has faced a decline of more than 27% as of Thursday's closing.
FDA Collaboration
According to Iovance, the FDA has expressed the need for additional time to review the biologics license application for this potential therapy due to its constrained resources. In a meeting held on Thursday, however, FDA staff "agreed to work closely with Iovance to expedite the remaining review," stated the company.
No Major Review Issues
The FDA also acknowledged that there are no significant review issues and that there are currently no plans to hold an advisory committee meeting.
Promising Milestone in Cancer Treatment
If approved, Lifileucel will be the first therapy for tumor-infiltrating lymphocytes in patients with advanced melanoma. Additionally, it will be recognized as the inaugural one-time cell therapy for solid tumor cancer.
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