ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency’s concerns.
The FDA has rejected ITM Isotope Technologies’ investigational tumor treatment, citing manufacturing and third-party facility inspection findings.
The agency issued a complete response letter (CRL) last week for ITM Isotope’s 177Lu-edotreotide, also known as ITM-11, a radiopharmaceutical designed to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to a Monday company release.
The FDA didn’t identify any clinical safety or efficacy issues with the cancer candidate, according to ITM Isotope.
“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,” the German biotech said in its release.
ITM Isotope is reviewing the feedback to determine next steps but said it plans on resubmitting its new drug application.
ITM-11 is a radiopharma therapy that bested Novartis’ mTOR inhibitor everolimus—sold as Afinitor, among other names—in the Phase 3 COMPETE study that evaluated 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,” ITM CEO Andrew Cavey said in a prepared statement. “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 in the FDA’s trove of CRLs. The agency has said it is continuing its “radical transparency” initiative of publishing CRLs soon after they are delivered despite a citizen petition filed earlier this year that questions the legality of the effort. Initially, the FDA had said it would pause the publication of the letters, a statement that was followed by the publication of several CRLs.
