FDA Nixes Indication on Secura’s Copiktra

Federal Register notice: FDA has announced that it is withdrawing approval of a Secura Bio indication for Copiktra (duvelisib) for treating relapsed or refractory follicular lymphoma. The indication gained accelerated approval 9/2018 and was required to conduct a postmarketing trial to verify the therapy’s clinical benefit. Because the company said the confirmatory trial was not underway and would not be conducted, the agency recommended that the indication be withdrawn. Subsequently, Secura notified the agency and requested it be withdrawn. Last month, FDA also withdrew Secura’s NDA for Farydak (panobinostat) capsules after the company requested the action. The company said the accelerated-approval drug, which is used in treating multiple myeloma, was not studied in a confirmatory postmarketing study because it was not feasible for them to complete it. To view the notice, click here.