Immunomedics, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, been notified by the FDA that a partial clinical hold has been placed on the company’s phase Ib/II clinical trial of clivatuzumab tetraxetan in patients with advanced pancreatic cancer, due to the administration of an incorrect dose to a patient enrolled at one of its trial sites.
This decision by the FDA was not due to safety issues of the product, but was based on a single incident in which a patient undergoing retreatment following a prior successful therapy cycle was administered a yttrium-90 (Y-90) dose higher than prescribed. After this error was discovered, no further doses were given to the patient, who remains on study with no critical toxicity. To date, there have been approximately 360 doses of clivatuzumab tetraxetan labeled with Y-90 successfully and correctly administered to almost 100 patients.
In response to this development, Cynthia L. Sullivan, president and CEO of Immunomedics, said, "We are preparing the requested remediation documents for the agency to ensure that this single error by the radiopharmacy will not reoccur in our trial, so that the partial clinical hold can be lifted as soon as possible. We are also working closely with the FDA to ensure patients who are eligible for retreatment can go on to receive additional cycles of therapy, once the partial hold is lifted. The phase Ib/II study is now fully enrolled, so we are hopeful to continue retreatment cycles for those patients who may benefit from this experimental therapy."