Secura Bio has voluntarily withdrawn the indication for Copiktra® (duvelisib) for the treatment of adults with relapsed or refractory follicular lymphoma after at least 2 prior systemic therapies.
In September 2018, Copiktra, an oral inhibitor of phosphoinositide 3-kinase, received accelerated approval for this indication based on overall response rate from the single-arm, multicenter phase 2 DYNAMO study (ClinicalTrials.gov Identifier: NCT01882803). Continued approval required further verification and description of clinical benefit in confirmatory trials.
The decision to withdraw the follicular lymphoma (FL) indication was made after the Company determined that the “current treatment landscape for FL patients in the United States and the logistics, cost and time of the post-marketing requirements for Copiktra in FL was no longer merited.”
The Company will be working with the FDA in the coming weeks to complete the label revision process. The withdrawal of the FL indication does not affect the other approved indication for Copiktra in the US and other countries. Copiktra is also indicated for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 prior therapies.
Health care providers with questions or concerns related to this withdrawal can contact Secura Bio at (805) 479-7793.
Secura Bio announces Copiktra® (duvelisib) strategic focus on T-cell lymphoma And voluntary US withdrawal of the relapsed or refractory follicular lymphoma indication. News release. Secura Bio, Inc. Accessed December 6, 2021. https://www.prnewswire.com/news-releases/secura-bio-announces-copiktra-duvelisib-strategic-focus-on-t-cell-lymphoma-and-voluntary-us-withdrawal-of-the-relapsed-or-refractory-follicular-lymphoma-indication-301436834.html.