The US Food and Drug Administration (FDA) has approved Copiktra (duvelisib) capsules for the treatment of relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL).
Manufacturing will take place at Catalent’s 450,000 square-feet Kansas City, Missouri facility, where the firm also conducts formulation development and analytical testing, clinical- and commercial-scale manufacturing and packaging of various oral dose forms.
Copiktra is an oral phosphoinositide 3-kinese (PI3K) inhibitor and the first inhibitor of PI3K-gamm for the treatment of patients with the aforementioned diseases.
The drug was developed during a multi-year collaboration, covering initial development and analytical support, between Catalent and Verastem Oncology.
Regulatory approval was accelerated based on overall response rate. Continued approval for this indication is dependent upon verification of clinical benefit in confirmatory trials.
A Catalent spokesperson told us the FDA had previously granted the drug fast-track designation in CLL and follicular lymphoma (FL). The FDA also granted an orphan drug designation for CLL/SLL and FL.
The drug was previously approved by the FDA for the indication of FL, under FDA regulations for accelerated approval.
The spokesperson explained that Catalent had also worked on duvelisib prior to the announcement, in 2016, when Verastem and Infinity Pharmaceuticals entered into a license agreement. This license agreement gave Verastem exclusive worldwide rights to develop and commercialize Infinity’s then drug candidate, duvelisib.