Redectane 124-Iodine-girentuximab regulatory update

Wilex said FDA suggested the company conduct an outcomes study of Redectane prior to submitting a BLA, despite concluding that a prior Phase III trial provided reasonable evidence of the cancer diagnostic's safety and efficacy. Wilex and commercialization partner IBA Group (Euronext:IBAB, Louvain-la-Neuve, Belgium) said they agree with FDA that an outcomes study is the next logical step for Redectane but believe the trial should be conducted as a Phase IV trial after market approval. Wilex is responsible for funding trials prior to approval, while IBA is responsible for postmarketing studies. The radiolabeled WX-G250 antibody is being developed as an aid in the pre-surgical diagnosis of clear cell renal cell cancer (RCC). Wilex said it will discuss the trial design and strategy with its medical advisory board and then present a proposal to FDA, but would not comment on timing. ...