The Food and Drug Administration has rejected ITM Isotope Technologies’ investigational tumor treatment, citing manufacturing and third-party facility inspection findings, according to an Aug. 11 company release.
The agency issued a complete response letter last week for ITM Isotope’s 177Lu-edotreotide, also known as ITM-11, a radiopharmaceutical designed to treat gastroenteropancreatic neuroendocrine tumors. The company said the FDA did not identify any clinical safety or efficacy issues with the cancer candidate.
“The CRL stated that the FDA is unable to approve the NDA in its present form and cited CMC- and third-party commercial facility-related items that must be addressed before the application can be approved,” ITM Isotope said in its release.
ITM Isotope is reviewing the feedback from regulators to determine next steps but plans on resubmitting its new drug application. The company highlighted that ITM-11 outperformed Novartis’ mTOR inhibitor everolimus in the Phase 3 COMPETE study evaluating progression-free survival for patients with advanced cancer.
“Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL,” CEO Andrew Cavey said. “Our pivotal COMPETE trial data package stands, and our goal remains unchanged as we work toward bringing ITM-11 to patients living with advanced GEP-NETs.”
The rejection letter is not yet listed among publicly available FDA documents. The agency has continued efforts toward greater transparency by publishing complete response letters soon after they are delivered.
