Duvelisib

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.

• COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.ICD-10: C85.90, C95.90

• None. None.contraindicated

25 mg orally, twice daily. Modify dosage for toxicity. ( 2.1 , 2.2 ) 2.1 Recommended Dosage The recommended dose of COPIKTRA 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. Advise patients not to open, break, or chew the capsules. Advise patients that if a dose is missed by fewer than 6 hours, to take the missed dose right away and take the next dose as usual. If a dose is missed by more than 6 hours, advise patients to wait and take the next dose at the usual time. 2.2 Recommended Prophylaxis Provide prophylaxis for Pneumocystis jirovecii (PJP) during treatment with COPIKTRA. Following completion of COPIKTRA treatment, continue PJP prophylaxis until the absolute CD4+ T cell count is greater than 200 cells/µL. Withhold COPIKTRA in patients with suspected PJP of any grade, and discontinue if PJP is confirmed. Consider prophylactic antivirals during COPIKTRA treatment to prevent cytomegalovirus (CMV) infection including CMV reactivation. 2.3 Dosage Modifications for Adverse Reactions Manage toxicities per Table 1 with dose reduction, treatment hold, or discontinuation of COPIKTRA. Table 1.

Hepatotoxicity: Monitor hepatic function. ( 5.6 ) Neutropenia: Monitor blood counts. ( 5.7 ) Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception. ( 5.8 ) 5.1 Treatment-related Mortality In a randomized controlled study in patients with relapsed or refractory CLL or SLL, treatment with COPIKTRA caused increased treatment-related mortality [see Clinical Studies ( 14 )] . With extended follow-up with a median of 63 months, treatment-related deaths occurred in 15% (23/158) of those patients in the overall population. In the indicated patient population, patients with relapsed or refractory CLL or SLL after at least two prior lines of systemic therapy, treatment-related deaths following treatment with COPIKTRA occurred in 14% (13/93) of patients. The most common cause of the treatment-related deaths were infections, which occurred in 9% and 11% of patients with relapsed or refractory CLL following at least one or two prior systemic therapies, respectively [see Adverse Reactions ( 6.1 )] . COPIKTRA is not indicated and is not recommended for any patients in the initial or second-line treatment setting [see Indications and Usage ( 1 )] . 5.2 Infections Serious, including fatal (18/442; 4%), infections occurred in 31% of patients receiving COPIKTRA 25 mg BID (N = 442). The most common serious infections were pneumonia, sepsis, and lower respiratory infections.

The following adverse reactions have been associated with COPIKTRA in clinical trials and are discussed in greater detail in other sections of the prescribing information: Treatment-related Mortality [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Diarrhea or Colitis [see Warnings and Precautions ( 5.3 )] Cutaneous Reactions [see Warnings and Precautions ( 5.4 )] Pneumonitis [see Warnings and Precautions ( 5.5 )] Hepatotoxicity [see Warnings and Precautions ( 5.6 )] Neutropenia [see Warnings and Precautions ( 5.7 )] The most common adverse reactions ( > 20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Secura Bio, Inc. (Secura Bio) at 1-844-973-2872, or U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely variable conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed in practice.

Lactation: Advise women not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and the mechanism of action, COPIKTRA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of duvelisib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes including embryo-fetal mortality (resorptions, post-implantation loss, and decreased viable fetuses), alterations to growth (lower fetal weights) and structural abnormalities (malformations) at maternal doses 10 times and 39 times the MRHD of 25 mg BID in rats and rabbits, respectively (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in rats, pregnant animals received daily oral doses of duvelisib of 0, 10, 50, 150 and 275 mg/kg/day during the period of organogenesis.

Metabolism

Duvelisib exposure increased in a dose-proportional manner over a dose range of 8 mg to 75 mg twice daily (0.3 to 3 times the recommended dosage). At steady state following 25 mg BID administration of duvelisib in patients, the geometric mean (CV%) maximum concentration (C max ) was 1.5 (64%) µg/mL and AUC was 7.9 (77%) µg•h/mL.

• Sep 24, 2018NDANDA211155Secura

1. 1Product Use In Unapproved Indication17823%
2. 2Diarrhoea10714%
3. 3Death10213%
4. 4Fatigue7810%
5. 5Off Label Use739.6%
6. 6Prescribed Underdose658.6%
7. 7Nausea496.5%
8. 8Pneumonia415.4%
9. 9Malignant Neoplasm Progression405.3%
10. 10Pyrexia385.0%
11. 11Hospitalisation354.6%
12. 12Rash344.5%
13. 13Asthenia324.2%
14. 14Disease Progression314.1%
15. 15Drug Ineffective304.0%

The 10 most recently updated of 59 ClinicalTrials.gov registrations naming Duvelisib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
  Suspended · Phase 2 · Interventional · 170 enrolled · Alliance for Clinical Trials in Oncology
  NCT04803201updated 2026-06-02
• Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas
  Recruiting · Phase 2 · Interventional · 25 enrolled · City of Hope Medical Center
  NCT07293403updated 2026-06-02
• A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)
  Recruiting · Phase 1 · Interventional · 30 enrolled · Memorial Sloan Kettering Cancer Center
  NCT07001384updated 2026-05-26
• Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
  Recruiting · Phase 2 · Interventional · 36 enrolled · Liling Zhang
  NCT05976997updated 2026-05-18
• Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
  Active not recruiting · Phase 1 · Interventional · 38 enrolled · National Cancer Institute (NCI)
  NCT04652960updated 2026-05-13
• Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas
  Terminated · Phase 2 · Interventional · 17 enrolled · Washington University School of Medicine
  NCT04331119updated 2026-05-06
• Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas
  Completed · Phase 1 · Interventional · 114 enrolled · Memorial Sloan Kettering Cancer Center
  NCT02783625updated 2026-04-24
• A Study of Ruxolitinib and Duvelisib in People With Lymphoma
  Recruiting · Phase 1 · Interventional · 70 enrolled · Memorial Sloan Kettering Cancer Center
  NCT05010005updated 2026-04-09
• A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype
  Recruiting · Phase 3 · Interventional · 124 enrolled · SecuraBio
  NCT06522737updated 2026-04-06
• Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 55 enrolled · Dana-Farber Cancer Institute
  NCT03534323updated 2026-03-23

Frequently asked questions

How does Duvelisib work?

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.

What is Duvelisib used for?

According to FDA labeling, Duvelisib carries indications including: COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Duvelisib?

Duvelisib is classified as Phosphatidylinositol-3-kinase (Pi3K) inhibitors, Kinase Inhibitors, Cellular Growth Phase Reduction, Decreased Cellular Migration, Decreased Cytokine Activity.

What are the brand names for Duvelisib?

Duvelisib is marketed under brand names including Copiktra.

What are the contraindications for Duvelisib?

Duvelisib labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.