Iovance Biotherapeutics: FDA Places Clinical Hold On IOV-LUN-202 Trial

(RTTNews) - Iovance Biotherapeutics, Inc. (IOVA) announced a clinical program update for LN-145 TIL therapy in non-small lung cancer. The FDA placed a clinical hold on the IOV-LUN-202 trial on December 22, 2023, in response to a Grade 5 serious adverse event. The company noted that the clinical hold has no impact on any other Iovance clinical trials and is independent of the FDA's Priority Review of the biologics license application for lifileucel in advanced melanoma. The BLA remains on track toward the PDUFA action date of February 24, 2024.

Iovance will pause enrollment and the LN-145 TIL treatment regimen for new patients in IOV-LUN-202 during the clinical hold.

Shares of Iovance Biotherapeutics are down 28% in pre-market trade on Wednesday.

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