IOVA - FDA Slaps Clinical Hold On Iovance Biotherapeutics' Lung Cancer Study After Patient Death | Benzinga
Wednesday, Iovance Biotherapeutics Inc (NASDAQ: IOVA) announced a clinical program update for LN-145 TIL therapy in non-small lung cancer (NSCLC).
The FDA placed a clinical hold on the IOV-LUN-202 trial on December 22, 2023, in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen.
During the clinical hold, Iovance will pause enrollment and the LN-145 TIL treatment regimen for new patients in IOV-LUN-202.
Patients previously treated with LN-145 ...