Verastem Oncology
Former TAP Partner
Verastem Oncology
Former TAP Partner
Copiktra® (duvelisib) is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and was the first approved dual inhibitor of PI3K-delta and gamma pathways by the U.S. Food and Drug Administration on September 24 2018 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and follicular lymphoma (FL). In December 2021, duvelisib was voluntarily withdrawn as a treatment for FL, as the logistics, costs, and timing needed to achieve post-marketing approval requirements could no longer be justified.
In December 2021, Copiktra was included in the National Comprehensive Cancer Network® T-Cell Lymphoma Guidelines® for the treatment of all subtypes of PTCL. Clinical data that supported the NCCN Guidelines inclusion was presented during the 2021 ASH meeting.
The Leukemia & Lymphoma Society's Therapy Acceleration Program® (TAP) committed $1.485 million in a partnership with Verastem Oncology between 2018-2020 to advance the therapy in PTCL. The clinical study that led to inclusion by the NCCN was supported in part by LLS TAP. Verastem sold the rights to duvelisib to Secura Bio in September 2020.
Recent News
Secura Bio Announces Final Patient Enrolled in PRIMO Study and Inclusion of COPIKTRA® (duvelisib) in NCCN Guidelines for PTCL
SUMMERLIN, Nev., Feb. 9, 2022 - Secura Bio, Inc. announced that it completed enrollment on February 1, 2022, in the PRIMO study. PRIMO is evaluating COPIKTRA (duvelisib) for the treatment of adult patients with relapsed or refractory (r/r) Peripheral T-cell Lymphoma (PTCL) and has enrolled a total of 157 patients. Primary endpoint analysis is expected later in 2022.
Shortly following the presentation of interim data from the PRIMO study at ASH, COPIKTRA was included in the National Comprehensive Cancer Network® T-Cell Lymphoma Guidelines® (Version 1.2022, 12/22/21) as a Category 2A designated option for the treatment of all subtypes of r/r PTCL.
Secura Bio Announces the Presentation of New COPIKTRA® (duvelisib) Data for the Treatment of Patients with Relapsed or Refractory PTCL
SUMMERLIN, Nev., Dec. 14, 2021 - Secura Bio, Inc., an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced that new data for the treatment of relapsed or refractory (r/r) PTCL patients with COPIKTRA (duvelisib) were presented at the 63rd annual meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.
Verastem Oncology Announces Closing of Duvelisib Sale to Secura Bio
BOSTON - Sep. 30, 2020 - Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced that it has completed the sale of Verastem's COPIKTRA (duvelisib), a marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, to Secura Bio, Inc.