The FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.
The FDA’s complete response letter did not raise any issues with ITM-11’s clinical or safety data, ITM clarified. Rather, the problems lie with its chemistry, manufacturing and controls and with a third-party commercial facility.
ITM’s application rested on data from the phase 3 Compete trial in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). These malignancies arise in a specialized group of neurons that secrete hormones, called neuroendocrine cells.
The German radiopharma, long an isotope supplier for others in the industry, previously shared that ITM-11 bested Novartis’ Afinitor at prolonging progression-free survival in the study, but did not show a statistically significant benefit in median overall survival.
“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,” Andrew Cavey, M.D., ITM’s chief exec, said in the company’s release. “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 radiopharma is committed to resubmitting ITM-11’s new drug application, according to the release.
ITM-11 contains a radioactive form of lutetium called lutetium-117, the same isotope that ITM supplies for Novartis’ blockbuster prostate cancer therapy Pluvicto. The Swiss pharma giant markets a rival neuroendocrine tumors therapy, Lutathera, which also uses lutetium-117.
ITM is also testing ITM-11 in a slew of other trials, including a phase 3 study for a different subset of patients with GEP-NETs. Another phase 3 trial is running in patients with lung and thymus neuroendocrine tumors, and ITM-11 is also being tested in a phase 1 pediatric trial in SSTR-positive tumors.
ITM’s pipeline also includes 10 other named assets, all in preclinical or phase 1 stages of development.