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Related Experiment Video

Updated: Feb 2, 2026

Labeling Stem Cells with Ferumoxytol, an FDA-Approved Iron Oxide Nanoparticle
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Duvelisib: First Global Approval.

Hannah A Blair1

  • 1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.

Drugs
|November 16, 2018
PubMed
Summary

Duvelisib (Copiktra™), a phosphatidylinositol-3 kinase inhibitor, is now approved for certain relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma patients. Its development milestones are summarized.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Duvelisib is an oral small-molecule inhibitor targeting phosphatidylinositol-3 kinase.
  • It is developed for various cancer indications, including hematological malignancies and solid tumors.

Purpose of the Study:

  • To summarize the key development milestones of duvelisib.
  • To highlight the regulatory approvals for chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma.

Main Methods:

  • Review of clinical development data for duvelisib.
  • Summary of regulatory submission and approval timelines.

Main Results:

  • Duvelisib received US approval in September 2018 for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

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  • Accelerated US approval was granted for relapsed/refractory follicular lymphoma (FL) after prior therapies.
  • Ongoing global clinical development for hematological malignancies and preclinical development for solid tumors.
  • Conclusions:

    • Duvelisib represents a new oral treatment option for specific B-cell malignancies.
    • The development journey highlights successful progression from preclinical to approved therapy.