• 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
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • 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 » Zydelig (idelalisib)

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

Zydelig (idelalisib)

  • Profile

Profile

Contact Information

Contact: Gilead Sciences
Website: https://www.zydelig.com/

Currently Enrolling Trials

    Show More

    General Information

    Zydelig (idelalisib) is a small molecule inhibitor of phosphoinositide-3 kinase (PI3K) delta, an intracellular signaling component. PI3K-delta is expressed primarily in blood-cell lineages, including cells that cause or mediate hematologic malignancies.

    Zydelig is specifically indicated for the following:

    • Relapsed chronic lymphocytic leukemia in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

    Zydelig was granted accelerated approval for relapsed follicular B-cell non-Hodgkin lymphoma in patients who have received at least two prior systemic therapies and relapsed small lymphocytic lymphoma in patients who have received at least two prior systemic therapies. These indications were voluntarily withdrawn in 2022.

    Zydelig is supplied as a tablet for oral administration. The recommended maximum starting dose of Zydelig is 150 mg administered orally twice daily. Zydelig can be taken with or without food. Tablets should be swallowed whole. Continue treatment until disease progression or unacceptable toxicity. 

    Mechanism of Action

    Zydelig (idelalisib) is a small molecule inhibitor of phosphoinositide-3 kinase (PI3K) delta, an intracellular signaling component. PI3K-delta is expressed primarily in blood-cell lineages, including cells that cause or mediate hematologic malignancies. Idelalisib induced apoptosis and inhibited proliferation in cell lines derived from malignant B-cells and in primary tumor cells. Idelalisib inhibits several cell signaling pathways, including B-cell receptor (BCR) signaling and the CXCR4 and CRCR5 signaling, which are involved in trafficking and homing of B-cells to the lymph nodes and bone marrow. Treatment of lymphoma cells with idelalisib resulted in inhibition of chemotaxis and adhesion, and reduced cell viability.

    Side Effects

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

    • diarrhea
    • pyrexia
    • fatigue
    • nausea
    • cough
    • pneumonia
    • abdominal pain
    • chills
    • rash

    Clinical Trial Results

    Zydelig was granted regular approval for use in patients with relapsed chronic lymphocytic leukemia (CLL). Accelerated approval was granted for relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL) based on overall response rate. Improvement in patient survival or disease related symptoms has not been established. Continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials. Gilead voluntarily withdrew the accelerated approval indications in 2022 after failing to complete confirmatory trials.

    Relapsed chronic lymphocytic leukemia

    Zydelig was evaluated in a randomized, double-blind, placebo-controlled study (Study 1) in 220 subjects with relapsed CLL who required treatment and were unable to tolerate standard chemoimmunotherapy. Subjects were randomized 1:1 to receive 8 doses of rituximab (first dose at 375 mg/m2, subsequent doses at 500 mg/m2 every 2 weeks for 4 infusions and every 4 weeks for an additional 4 infusions) in combination with either an oral placebo twice daily or with Zydelig 150 mg taken twice daily until disease progression or unacceptable toxicity. The primary endpoint was progression free survival (PFS). The subjects who received Zydelig in combination with rituximab went approximately 11 months without disease pregression, compared to approximately 6 months for subjects given rituximab and a placebo (p < 0.0001).

    Relapsed follicular B-cell non-Hodgkin lymphoma

    A single-arm, multicenter clinical trial enrolled 72 subjects with follicular B-cell non-Hodgkin lymphoma who had relapsed within 6 months following rituximab and an alkylating agent and had received at least 2 prior treatments. Subjects received 150 mg of Zydelig orally twice daily until evidence of disease progression or unacceptable toxicity. The primary endpoint was Independent Review Committee-assessed overall response rate. Zydelig achieved an overall response rate of 54%; 8% were complete responses and 46% were partial responses. The median duration of response was not reached.

    Relapsed Small Lymphocytic Lymphoma

    A single-arm, multicenter clinical trial enrolled 26 subjects with small lymphocytic lymphoma who had relapsed within 6 months following rituximab and an alkylating agent and had received at least 2 prior treatments. Subjects received 150 mg of Zydelig orally twice daily until evidence of disease progression or unacceptable toxicity. The primary endpoint was Independent Review Committee-assessed overall response rate. Zydelig achieved an overall response rate of 58%; all responses were partial responses. The median duration of response was 11.9 months.

    Approval Date: 2014-07-01
    Company Name: Gilead Sciences
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Revamp-360x240.png

      Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

    • AskTheExpertsGreen-360x240.png

      Ask the Experts: Managing Investigational Products

    • SurveywBlueBackground-360x240.png

      Survey Outlines Site Challenges, Successes on Diversity

    • PatientCentricity-360x240.png

      Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

    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 or Share My Data

    Footer Logo

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

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing