Omapro is used for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation.
ChemGenex Pharmaceuticals said that the FDA has neither requested the company to conduct a new study nor requested for additional patient enrollment into the pivotal study on Omapro.
Greg Collier, CEO of ChemGenex Pharmaceuticals, said: “The complete response letter from the FDA provides the initial guidance towards our endeavor to bring a new therapy to CML patients who harbour the T315I mutation and currently have very limited or unsatisfactory treatment options.
“Because the principal issues raised by the FDA were similar to those discussed during the 22 March meeting of the Oncology Drug Advisory Committee (ODAC), and based upon our interpretation of the scientific requirements underpinning the complete response letter, we are confident that we can work in a positive manner with the FDA to address the outstanding matters.
“We appreciate the constructive comments made by the agency in the response letter and ChemGenex Pharmaceuticals will seek a meeting with the FDA to discuss and find agreeable solutions for each of the FDA’s requests.”
Reportedly, ChemGenex Pharmaceuticals also had a word with the FDA’s Center for Devices and Radiological Health (CDRH) on April 9th, to discuss a path forward for the development of a well defined diagnostic test for the T315I mutation. Both the parties agreed to work together toward the validation of the T315I assay that meets the FDA’s requirements.