Telix Gets Second FDA Rejection For Kidney Cancer Drug

On Thursday, Telix Pharmaceuticals Limited TLX received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix, 89Zr-DFO girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).The CRL identifies deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package.The FDA has requested additional data to establish c ...