• 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 » Daurismo (glasdegib)

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

Daurismo (glasdegib)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Daurismo (glasdegib) is a hedgehog pathway inhibitor. 

    Daurismo is specifically indicated for use in combination with low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

    Daurismo is supplied as a tablet for oral administration. The recommended dose of is 100 mg orally once daily on days 1 to 28 in combination with cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control. For patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response.

    Daurismo can be taken with or without food and should be administered about the same time each day. Do not split or crush tablets. If a dose of Daurismo is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of Daurismo is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer two doses of Daurismo within 12 hours.

    Clinical Results

    FDA Approval

    The FDA approval of Daurismo was based on the pivotal, randomized, international Phase II trial BRIGHT 1003. The trial enrolled 115 patients with newly diagnosed AML who were randomized 2:1 to receive Daurismo plus low-dose cytarabine (LDAC) or LDAC alone. Of the 77 patients treated with Daurismo plus LDAC, more than half (51%, 39 patients) had secondary AML, or AML that develops as a result of prior blood/bone marrow conditions or previous anticancer therapy. Eleven of the 39 patients with secondary AML received prior treatment with a hypomethylating agent. Median overall survival was 8.3 months for patients treated with Daurismo plus LDAC compared with 4.3 months for patients treated with LDAC alone. This difference represented a 54 percent reduction in the risk of death for patients treated with Daurismo plus LDAC.

    Side Effects

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

    anemia

    fatigue

    hemorrhage

    febrile neutropenia

    musculoskeletal pain

    nausea

    edema

    thrombocytopenia

    dyspnea

    decreased appetite

    dysgeusia

    mucositis

    constipation

    rash

    The Daurismo drug label comes with the following Black Box Warning: Daurismo can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Daurismo is embryotoxic, fetotoxic, and teratogenic in animals. Pregnancy testing should be conducted in females of reproductive potential prior to initiation of Daurismo treatment. Advise females of reproductive potential to use effective contraception during treatment with Daurismo and for at least 30 days after the last dose.  Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with Daurismo and for at least 30 days after the last dose to avoid potential drug exposure.

    Mechanism of Action

    Daurismo (glasdegib) is a hedgehog pathway inhibitor. Glasdegib binds to and inhibits Smoothened, a transmembrane protein involved in hedgehog signal transduction. The Hedgehog signaling pathway plays an essential role in embryogenesis, the process by which human embryos are developed. In adults, however, abnormal activation of this pathway is thought to contribute to the development and persistence of cancer stem cells.

    Additional Information

    For additional information regarding Daurismo or newly-diagnosed acute myeloid leukemia in adults 75 years of age or older, please visit https://www.daurismo.com/

    Approval Date: 2018-11-01
    Company Name: Pfizer
    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

    • TechInnovation-360x240.png

      Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

    • AskTheExperts-360x240.png

      Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

    • 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

    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