• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Copiktra (duvelisib)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Copiktra (duvelisib)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Copiktra (duvelisib) is a dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells.

    Copiktra is specifically indicated for the treatment of adults with 1) relapsed or refractory chronic lymphocytic leukemia, 2) small lymphocytic lymphoma after at least two prior therapies and 3) relapsed or refractory follicular lymphoma after at least two prior systemic therapies. 

    Copiktra is supplied as a capsule for oral administration. The recommended dose is  25 mg administered as oral capsules twice daily (BID) with or without food. A cycle consists of 28 days. The capsules should be swallowed whole. The capsules should not be opened, broken, or chewed. If a dose is missed by fewer than 6 hours, take the missed dose right away and take the next dose as usual. If a dose is missed by more than 6 hours, wait and take the next dose at the usual time. See drug label for specific dose modifications due to adverse reactions.

    Clinical Results

    FDA Approval

    The FDA approval of Copiktra for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma was based on the phase III DUO study. The study enrolled 319 patients who were randomized 1:1 to receive either duvelisib 25mg orally twice daily or ofatumumab monotherapy, an approved standard of care treatment for use in CLL/SLL, per its label with an initial infusion of 300 mg followed by 7 weekly infusions and 4 monthly infusions of 2,000 mg. The DUO study met its primary endpoint with oral duvelisib monotherapy achieving a statistically significant improvement in median PFS (mPFS) compared to ofatumumab in per a blinded Independent Review Committee using iwCLL or revised IWG Response Criteria (modified iwCLL/IWG; 13.3 months vs 9.9 months, respectively), representing a 48% reduction in the risk of progression or death.

    The FDA approval of Copiktra for relapsed or refractory follicular lymphoma was based on the DYNAMO study. The study enrolled 129 patients with iNHL who were refractory to rituximab (Rituxan) and either chemotherapy or radioimmunotherapy. Among the 129 enrolled patients, the disease types included follicular lymphoma (n = 83), SLL (n = 28), and marginal zone lymphoma (n = 18). Continuous duvelisib was administered at 25 mg twice daily. In the DYNAMO study, duvelisib demonstrated an overall response rate of 46% for patients with iNHL, including 41% in patients with follicular lymphoma.

    Side Effects

    Adverse effects associated with the use of Copiktra may include, but are not limited to, the following:

    diarrhea or colitis

    neutropenia

    rash

    fatigue

    pyrexia

    cough

    nausea

    upper respiratory infection

    pneumonia

    musculoskeletal pain

    anemia

    The Copiktra drug label comes with the following Black Box Warning:

    Fatal and/or serious infections occurred in 31% of Copiktra treated patients. Monitor for signs and symptoms of infection. Withhold Copiktra if infection is suspected. Fatal and/or serious diarrhea or colitis occurred in 18% of Copiktra-treated patients. Monitor for the development of severe diarrhea or colitis. Fatal and/or serious cutaneous reactions occurred in 5% of Copiktra-treated patients. Fatal and/or serious pneumonitis occurred in 5% of Copiktra-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. 

    Mechanism of Action

    Copiktra (duvelisib) is an inhibitor of PI3K with inhibitory activity predominantly against PI3K-δ and PI3K-γ isoforms expressed in normal and malignant B-cells. Duvelisib induced growth inhibition and reduced viability in cell lines derived from malignant B-cells and in primary CLL tumor cells. Duvelisib inhibits several key cell-signaling pathways, including B-cell receptor signaling and CXCR12-mediated chemotaxis of malignant B-cells. Additionally, duvelisib inhibits CXCL12-induced T cell migration and M-CSF and IL-4 driven M2 polarization of macrophages. 

    Additional Information

    For additional information regarding Copiktra or relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma or follicular lymphoma, please visit https://www.copiktra.com/

    Approval Date: 2018-09-01
    Company Name: Verastem
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • Resources-360x240.png

      Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

    • FocusinRed-360x240.png

      Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

    • VaccinewithNeedle-360x240.png

      2021 Vaccine Industry Will Continue to be Dominated by COVID-19 Trials, Experts Say

    • Dominate-360x240.png

      COVID-19, Oncology, CNS and Infectious Disease Trials Will Dominate in 2021, Survey Predicts

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing