FDA Lifts Hold, Allows Iovance Biotherapeutics to Resume Enrollment in Lung Cancer Trial

Iovance Biotherapeutics received approval from the FDA to restart enrollment in its phase 2 trial, IOV-LUN-202, after a partial clinical hold was imposed in December 2023. The hold was triggered by a grade 5 adverse event, involving patient fatality potentially linked to the preconditioning regimen of tumor-infiltrating lymphocyte therapy LN-145. Despite the setback, Iovance swiftly addressed the concerns by collaborating with the FDA and an independent data monitoring committee, proposing additional safety measures and monitoring for the trial. The FDA's recent green light to resume enrollment is a positive development for Iovance, following the FDA's approval of its lead asset, lifileucel, for advanced melanoma in the previous month.

This regulatory progress has contributed to a notable rebound in Iovance's share price, rising almost 10% to $18.45 in premarket trading. The company anticipates completing enrollment of around 120 patients in the IOV-LUN-202 registrational cohorts by 2025. The approval of lifileucel, now marketed as Amtagvi, marks a significant milestone as the first T-cell therapy approval for a solid tumor indication, providing a boost to Iovance's position in the biotech landscape.

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