COPIKTRA (duvelisib) for T-cell lymphoma – pro
Duvelisib, sold under the brand name Copiktra, is a medication approved in 2018 to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after other treatments have failed. Duvelisib, a dual PI3K-, inhibitor, showed activity in patients with relapsed/refractory PTCL and cutaneous T-cell lymphoma in small phase 1 studies, and was granted Fast Track Designation by the FDA for the treatment of PTCL who had received 1 prior therapy. While there are no large scale studies, FDA has granted an ophan drug designation for T-cell lymphoma.
COPIKTRA (duvelisib)” (PDF). U.S. Food and Drug Administration. Retrieved 23 October 2020.
Horwitz SM, Meta-Shat N, Pro B, et al. Dose optimization of duvelisib in patients with relapsed or refractory peripheral T-cell lymphoma from the phase 2 Primo trial. Presented at: American Society of Hematology Annual Meeting; December 7-10, 2019; Orlando, FL. Abstract 1567. bit.ly/2DZ4Xnb.
Verastem Oncology Receives Orphan Drug Designation from FDA for COPIKTRA for the Treatment of T-Cell Lymphoma [press release]. Boston, MA: Verastem, Inc.; October 3, 2019. https://bwnews.pr/332o768. Accessed October 4, 2019.
Horwitz SM, Foss FM, Porcu P, et al. Duvelisib, an oral dual PI3K-, inhibitor, efficacy and safety in patients with relapsed or refractory (RR) peripheral T-cell lymphoma: rationale for the phase 2 PRIMO trial. Presented at: 15th International Conference on Malignant Lymphoma; June 18-22, 2019; Lugano, Switzerland. Abstract 033.