FDA Lifts Clinical Hold On Iovance Biotherapeutics' IOV-LUN-202 Study In Non-Small Cell Lung Cancer

(RTTNews) - Iovance Biotherapeutics, Inc. (IOVA) Monday said the Food and Drug Administration (FDA) has lifted a partial clinical hold placed on the registrational IOV-LUN-202 study of its LN-145 TIL cell therapy in non-small cell lung cancer (NSCLC).

After reviewing the company's proposal to develop additional safety measures and monitoring, the FDA has cleared Iovance to resume patient enrollment in IOV-LUN-202, the company said in a statement.

In December last year, the FDA had placed a clinical hold on the IOV-LUN-202 trial in response to a Grade 5 (fatal) serious adverse event potentially related to non-myeloablative lymphodepletion pre-conditioning regimen.

The company expects to complete enrollment in the IOV-LUN-202 registrational study in 2025.