Posted by Michael Wonder on 06 Dec 2021
Secura Bio announces Copiktra (duvelisib) strategic focus on T-cell lymphoma and voluntary U.S. withdrawal of the relapsed or refractory follicular lymphoma indication
3 December 2021 - Secura Bio has voluntarily withdrawn the U.S. Copiktra indication for the treatment of patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies.
The relapsed or refractory follicular lymphoma indication received accelerated approval in September 2018 with the requirement that an additional confirmatory trial be conducted in order for the product to be granted full approval.
