Telix Pharma Hit with Refuse-to-File on BLA

FDA has issued Telix Pharmaceuticals a refuse-to-file letter on its BLA for TLX250-CDx (89Zr-DFO-girentuximab), an investigational imaging agent for clear cell renal cell carcinoma. “During the 60-day administrative review, the FDA has identified a filing issue in the chemistry, manufacturing and controls (CMC) package,” the company says, adding that the concern relates to demonstrating adequate sterility assurance during dispensing in the radiopharmacy production environment.

“Telix can confirm that despite this concern raised by the FDA, all process performance qualification (PPQ) batches submitted as part of the BLA application passed the sterility requirements of product release,” the company says. “The FDA has indicated that this issue will require remediation in order for the application to advance to full review.”

Telix expects to be able to complete remedial actions within 90 days and says it will then resubmit the BLA.