Copiktra (Duvelisib)
Dual PI3K-delta/gamma inhibitor for relapsed or refractory CLL/SLL
Copiktra (duvelisib) is an oral phosphoinositide 3-kinase (PI3K) inhibitor that targets both the delta and gamma isoforms of PI3K. It was approved by the FDA in 2018 under accelerated approval for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies. Copiktra carries four FDA black box warnings for infections, diarrhea/colitis, cutaneous reactions, and pneumonitis. Patients must be informed of these serious risks before starting treatment.
Quick Facts
Key Takeaways
- Copiktra (duvelisib) is a dual PI3K-delta/gamma inhibitor used for relapsed or refractory CLL/SLL after at least two prior therapies.
- The standard dose is 25 mg orally twice daily, with a first dose reduction to 15 mg twice daily if needed.
- Four FDA black box warnings highlight the risks of fatal infections, severe diarrhea/colitis, cutaneous reactions (including SJS/TEN), and pneumonitis.
- PJP prophylaxis is mandatory throughout treatment and for at least 2 months after discontinuation, with monthly CMV monitoring required.
- Copiktra has been withdrawn from the U.S. market; patients should discuss current availability and alternative therapies with their oncologist.
What Is Copiktra and What Is It Used For?
Copiktra is the brand name for duvelisib, a targeted anticancer therapy developed for the treatment of specific types of blood cancers. Classified as a phosphoinositide 3-kinase (PI3K) inhibitor, duvelisib uniquely targets both the delta and gamma isoforms of the PI3K enzyme. This dual mechanism of action distinguishes it from other PI3K inhibitors that target only one isoform, providing a broader approach to disrupting cancer cell signaling and modifying the tumor microenvironment.
The PI3K/AKT signaling pathway is one of the most commonly dysregulated pathways in B-cell malignancies such as CLL and SLL. PI3K-delta is primarily expressed in hematopoietic (blood-forming) cells and plays a critical role in B-cell proliferation, survival, homing, and migration. When this pathway becomes hyperactive in cancerous B cells, it drives unchecked cell growth and resistance to apoptosis (programmed cell death). By inhibiting PI3K-delta, duvelisib directly induces apoptosis in malignant B cells and impairs their ability to proliferate.
The gamma isoform of PI3K serves a complementary but equally important function. PI3K-gamma is expressed in leukocytes and plays a key role in modulating the tumor microenvironment—the complex ecosystem of immune cells, stromal cells, and signaling molecules that surround and support tumor growth. Specifically, PI3K-gamma influences T-regulatory cells and tumor-associated macrophages that often create an immunosuppressive environment favorable to cancer cell survival. By inhibiting PI3K-gamma, duvelisib disrupts these supportive signals and may help restore anti-tumor immune activity.
The FDA granted accelerated approval to Copiktra on September 24, 2018, for two indications: adult patients with relapsed or refractory CLL/SLL after at least two prior therapies, and adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The CLL/SLL indication was supported by the DUO trial, a randomized Phase 3 study comparing duvelisib to ofatumumab. The FL indication was based on the DYNAMO trial, a single-arm Phase 2 study. The follicular lymphoma indication was voluntarily withdrawn in November 2021 after a confirmatory trial did not meet its primary endpoint.
Key Clinical Trial Results
In the pivotal DUO trial, duvelisib demonstrated a significant improvement in progression-free survival (PFS) compared to ofatumumab. The median PFS was 13.3 months for duvelisib compared to 9.9 months for ofatumumab, with a hazard ratio of 0.52 (indicating a 48% reduction in the risk of disease progression or death). The overall response rate (ORR) was 74% for duvelisib versus 45% for ofatumumab, confirming the clinical activity of the drug in this patient population.
In the DYNAMO trial for follicular lymphoma, duvelisib achieved an overall response rate of 42% in patients with double-refractory disease, with a median duration of response of approximately 7.9 months. While these results demonstrated activity, the subsequent confirmatory trial did not confirm clinical benefit, leading to the voluntary withdrawal of this indication.
Copiktra has been withdrawn from the U.S. market by the manufacturer. Both the CLL/SLL and FL indications have been discontinued. This was primarily due to the benefit-risk profile in the context of newer, better-tolerated therapies such as BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib) and the BCL-2 inhibitor venetoclax. Patients should discuss current treatment options with their oncologist.
What Should You Know Before Taking Copiktra?
Copiktra is a potent medication with significant risks that require careful consideration before starting therapy. The FDA prescribing information includes four separate black box warnings—the most serious type of safety alert—for potentially fatal and serious adverse reactions. Every patient must be thoroughly informed about these risks and the monitoring requirements before initiating treatment. Your oncologist will conduct a comprehensive baseline assessment and establish a monitoring schedule to help manage these risks.
Contraindications
Copiktra is contraindicated in patients with a history of serious hypersensitivity reactions to duvelisib or any excipient (inactive ingredient) in the formulation. Serious hypersensitivity includes anaphylaxis and severe dermatologic reactions such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). If you have experienced any severe allergic reaction to a PI3K inhibitor in the past, inform your healthcare provider, as cross-reactivity may occur. There are no other absolute contraindications, but several warnings and precautions significantly influence the decision to start treatment.
Warnings and Precautions
Copiktra carries four black box warnings for potentially fatal adverse events:
- Infections: Fatal and/or serious infections occurred in 31% of patients, with 1.4% being fatal. Patients must be monitored for signs and symptoms of infection, and treatment should be withheld for Grade 3 or higher infections.
- Diarrhea/Colitis: Fatal and/or serious diarrhea or colitis occurred in 18% of patients (Grade 3+). The median time to onset was approximately 9 months. Patients should report any new or worsening diarrhea immediately.
- Cutaneous Reactions: Fatal and/or serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Treatment must be discontinued for any Grade 3 or higher cutaneous reaction or any suspicion of SJS/TEN.
- Pneumonitis: Fatal and/or serious non-infectious pneumonitis occurred in 5% of patients (Grade 3 in 2.5%). Treatment must be permanently discontinued for any grade of pneumonitis.
Beyond the black box warnings, additional precautions include hepatotoxicity (liver damage), which can be fatal or serious. Liver function tests (ALT, AST, bilirubin) must be monitored before starting treatment, at least every 2 weeks for the first 2 months, and at least monthly thereafter. Dose modifications or discontinuation may be necessary based on the severity of transaminase or bilirubin elevations.
Severe neutropenia (abnormally low neutrophil counts) is another significant concern, occurring at Grade 3-4 severity in up to 42% of patients. Complete blood counts must be monitored at least every 2 weeks for the first 2 months and at least monthly after that. Neutropenia increases the risk of infections and may require dose interruption or reduction.
Cytomegalovirus (CMV) infection or reactivation has been observed during Copiktra treatment. Patients must undergo monthly CMV monitoring by PCR or antigen testing throughout treatment. If CMV viremia (virus in the blood) is detected without clinical symptoms, treatment should be held. If CMV disease develops (with clinical symptoms such as retinitis, pneumonia, or colitis), treatment should be permanently discontinued.
Pregnancy and Breastfeeding
Based on its mechanism of action and findings in animal reproduction studies, Copiktra can cause fetal harm when administered to pregnant women. Animal studies showed embryo-fetal toxicity including post-implantation loss, malformations, and decreased fetal weight at exposures lower than those achieved at the recommended human dose. There are no adequate human data on the use of Copiktra during pregnancy.
Women of reproductive potential should undergo pregnancy testing before starting treatment and must use effective contraception during treatment and for at least 1 month after the last dose. Men with female partners of reproductive potential should also be counseled about potential effects on fertility, as animal studies suggest duvelisib may impair male fertility.
It is not known whether duvelisib or its metabolites are present in human breast milk. Due to the potential for serious adverse reactions in breastfed infants, women are advised not to breastfeed during treatment and for at least 1 month after the last dose.
Required Prophylaxis and Monitoring
- PJP prophylaxis: Pneumocystis jirovecii pneumonia prophylaxis (e.g., trimethoprim-sulfamethoxazole) is required throughout treatment and for at least 2 months after discontinuation.
- CMV monitoring: Monthly PCR or antigen testing throughout treatment.
- Liver function tests: Before treatment and at least every 2 weeks for the first 2 months, then monthly.
- Complete blood counts: At least every 2 weeks for the first 2 months, then monthly.
- Pregnancy testing: Verify negative status before initiating therapy.
How Does Copiktra Interact with Other Drugs?
Understanding drug interactions is essential for the safe use of Copiktra, as duvelisib is primarily metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme system and is also a moderate inhibitor of this same enzyme. This dual role means that Copiktra can both be affected by and affect the metabolism of many other drugs. Your oncologist and pharmacist should conduct a thorough review of all medications—including prescription drugs, over-the-counter medicines, herbal supplements, and dietary products—before starting treatment.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir) | Significantly increases duvelisib exposure | Reduce Copiktra dose to 15 mg twice daily |
| Strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St. John's Wort) | Significantly decreases duvelisib exposure | Avoid concomitant use |
| Sensitive CYP3A4 substrates (midazolam, certain statins, cyclosporine, sirolimus) | Duvelisib increases levels of these drugs | Monitor closely; consider dose reduction of the substrate |
| Hepatotoxic drugs (acetaminophen at high doses, methotrexate, isoniazid) | Increased risk of liver injury | Monitor liver function more frequently |
| Live vaccines (MMR, varicella, yellow fever, BCG) | Risk of uncontrolled infection from the vaccine organism | Avoid during treatment and for at least 2 months after |
Minor Interactions
Moderate CYP3A4 inhibitors such as erythromycin, fluconazole, diltiazem, and verapamil may increase duvelisib exposure to a lesser degree than strong inhibitors. While a formal dose reduction is not mandated, close monitoring for adverse effects is recommended, and dose reduction should be considered if toxicity develops.
Grapefruit and grapefruit juice contain compounds that inhibit CYP3A4 in the gut wall and can increase the absorption and systemic exposure of duvelisib. Patients should be advised to avoid grapefruit and grapefruit juice during treatment with Copiktra.
Duvelisib is also a substrate of P-glycoprotein (P-gp), a drug transport protein. Drugs that strongly inhibit P-gp (such as cyclosporine, quinidine, and verapamil) may further increase duvelisib plasma levels, particularly in the gut. While the clinical significance of this interaction is less well characterized than the CYP3A4 interactions, awareness is important when multiple interacting drugs are used concurrently.
Immunosuppressive medications, including corticosteroids and other immunomodulators, may have additive immunosuppressive effects when combined with Copiktra. Given that Copiktra already causes significant immunosuppression (as evidenced by the high infection rate), concomitant use of additional immunosuppressants should be carefully weighed against the potential benefits.
What Is the Correct Dosage of Copiktra?
Copiktra is available as hard gelatin capsules in two strengths: 25 mg and 15 mg. The capsules should be swallowed whole and must not be opened, broken, or chewed. Copiktra can be taken with or without food, as food does not significantly affect the drug's absorption or systemic exposure. Patients should aim to take their doses approximately 12 hours apart to maintain consistent drug levels.
Adults
Standard Adult Dosing
Starting dose: 25 mg orally twice daily
First dose reduction: 15 mg orally twice daily
Second dose reduction: Permanently discontinue
Duration: Continue until disease progression or unacceptable toxicity
| Adverse Reaction | Severity | Action |
|---|---|---|
| ALT/AST elevation | 3-5x ULN | Hold until ≤1x ULN, resume at 15 mg BID |
| ALT/AST elevation | >20x ULN | Permanently discontinue |
| Diarrhea/Colitis | Grade 2 | Hold until resolved; resume at 25 mg or 15 mg BID |
| Diarrhea/Colitis | Grade 3-4 | Hold until resolved; discontinue if recurrent |
| Pneumonitis | Any grade | Permanently discontinue |
| Neutropenia (ANC) | <500/μL | Hold until ANC >500, then resume at same or reduced dose |
| Cutaneous reactions | Grade 3 | Hold until resolved; resume at reduced dose |
| SJS/TEN | Any | Permanently discontinue |
Children
The safety and effectiveness of Copiktra have not been established in pediatric patients. There are no approved pediatric dosing recommendations. Copiktra should not be used in patients under 18 years of age unless directed by a specialist within the context of a clinical trial.
Elderly
No specific dose adjustment is recommended for elderly patients based solely on age. However, elderly patients are more likely to have reduced hepatic and renal function, as well as comorbidities that may increase the risk of adverse effects. In clinical trials, patients aged 65 years and older experienced a higher frequency of serious adverse reactions, particularly infections and diarrhea. Careful monitoring and a lower threshold for dose modification may be appropriate in this population.
Missed Dose
If a dose of Copiktra is missed by less than 6 hours, the patient should take the missed dose as soon as they remember and then resume the regular dosing schedule. If more than 6 hours have elapsed since the missed dose, the patient should skip the missed dose entirely and take the next dose at the regularly scheduled time. Under no circumstances should the patient take a double dose to make up for a missed dose, as this could increase the risk of serious side effects.
Overdose
There is no specific antidote for duvelisib overdose. In the event of a suspected overdose, Copiktra should be withheld immediately, and the patient should be monitored closely for signs and symptoms of adverse reactions. Treatment is supportive and symptomatic. Hemodialysis is unlikely to be effective in removing duvelisib from the bloodstream, given the drug's high protein binding (approximately 97-98%). Emergency medical services should be contacted immediately if an overdose is suspected.
What Are the Side Effects of Copiktra?
Copiktra has a significant side effect profile that reflects both its mechanism of action (broad immunosuppression through PI3K inhibition) and the vulnerability of the patient population (heavily pretreated cancer patients with compromised immune function). The adverse reactions observed in clinical trials are broadly categorized by their frequency of occurrence, ranging from very common to rare. Understanding these side effects is essential for patients and caregivers to recognize early warning signs and seek prompt medical attention.
It is important to note that many of these side effects can be managed through dose modifications, supportive care, and prophylactic measures. However, some adverse reactions—particularly pneumonitis and SJS/TEN—require permanent discontinuation of the drug. Regular monitoring through blood tests, clinical assessments, and patient self-reporting is critical throughout the course of treatment.
Very Common (>1/10 patients)
- Diarrhea/colitis (31-51%)
- Infections including pneumonia, URI, sepsis (31-69%)
- Neutropenia (33-42%)
- Anemia (24-32%)
- Thrombocytopenia (16-28%)
- Transaminase elevations, ALT/AST increase (25-47%)
- Nausea (21-26%)
- Fatigue/asthenia (18-28%)
- Pyrexia/fever (14-23%)
- Rash (15-22%)
- Cough (12-21%)
- Musculoskeletal pain (14-20%)
- Decreased appetite (10-15%)
- Dyspnea (10-14%)
Common (1/10 – 1/100 patients)
- Pneumocystis jirovecii pneumonia (PJP)
- CMV infection/reactivation
- Sepsis
- Abdominal pain
- Stomatitis/mucositis
- Vomiting, constipation
- Pneumonitis (non-infectious lung inflammation)
- Exfoliative dermatitis
- Stevens-Johnson syndrome (SJS)
- Pruritus (itching)
- Headache
- Edema (swelling)
- Weight decrease
- Hyperglycemia
- Lipase increase
Uncommon (1/100 – 1/1,000 patients)
- Toxic epidermal necrolysis (TEN)
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Anaphylaxis
Rare (<1/1,000 patients)
- Progressive multifocal leukoencephalopathy (PML)
- Tumor lysis syndrome
Laboratory Abnormalities
In clinical trials, laboratory abnormalities were frequently observed and often guided dose modifications. The most common laboratory findings included:
- Decreased neutrophil count: 74% all grades, 42% Grade 3-4
- Decreased hemoglobin: 60% all grades, 12% Grade 3-4
- Decreased platelet count: 55% all grades, 16% Grade 3-4
- Increased ALT: 47% all grades, 8% Grade 3-4
- Increased AST: 36% all grades, 5% Grade 3-4
- Increased lipase: 25% all grades, 14% Grade 3-4
These laboratory abnormalities underscore the importance of regular blood monitoring throughout treatment. Patients should have complete blood counts and liver function tests performed at least every 2 weeks during the first 2 months of therapy, and at least monthly thereafter. Any significant deterioration in laboratory values should prompt consideration of dose modification or discontinuation.
Contact your healthcare provider or seek emergency care immediately if you experience: new or worsening fever or signs of infection, persistent or bloody diarrhea, new or worsening cough or shortness of breath, new skin rash or blistering, or yellowing of the skin or eyes (jaundice).
How Should You Store Copiktra?
Proper storage of Copiktra is essential to maintain the drug's stability, potency, and safety throughout the treatment course. Duvelisib capsules should be stored at controlled room temperature between 20°C and 25°C (68°F to 77°F). Brief temperature excursions are permitted between 15°C and 30°C (59°F to 86°F), such as may occur during normal transportation or short periods without air conditioning.
The capsules should be kept in their original container to protect them from moisture. The container closure system is specifically designed to provide adequate moisture protection for the formulation. Patients should not transfer capsules to other containers, pill organizers, or plastic bags for extended periods, as this may expose the medication to humidity that could degrade its effectiveness.
As with all medications, Copiktra must be kept out of the reach and sight of children and pets. This is particularly important given the drug's potency and the potential for serious harm if ingested accidentally. Copiktra is a cytotoxic medication, and caregiver exposure should be minimized. Caregivers should avoid direct skin contact with broken or damaged capsules and should wash their hands thoroughly after handling the medication.
Do not use Copiktra after the expiration date printed on the container label. Expired medication should be disposed of according to local pharmaceutical waste disposal guidelines. Do not flush medications down the toilet or pour them into drains unless specifically instructed to do so. Many pharmacies and healthcare facilities offer medication take-back programs for safe disposal of unused or expired cancer medications.
What Does Copiktra Contain?
Copiktra capsules contain duvelisib as the active pharmaceutical ingredient. The chemical name for duvelisib is 8-chloro-2-phenyl-3-[(1S)-1-(7H-purin-6-ylamino)ethyl]-1(2H)-isoquinolinone, with a molecular formula of C22H17ClN6O and a molecular weight of 416.86 g/mol. Duvelisib is a white to off-white powder that is practically insoluble in water.
Active Ingredient
- Duvelisib: 25 mg per capsule (standard strength) or 15 mg per capsule (reduced dose strength)
Inactive Ingredients (Excipients)
The capsule fill contains the following inactive ingredients that serve specific pharmaceutical functions:
- Colloidal silicon dioxide: A flow agent that prevents powder clumping during manufacturing
- Crospovidone: A disintegrant that helps the capsule contents break apart in the stomach for proper dissolution
- Magnesium stearate: A lubricant that prevents the powder from sticking to manufacturing equipment
- Microcrystalline cellulose: A filler and binder that provides bulk and structural integrity to the capsule contents
- Pregelatinized starch (maize): A binder and disintegrant derived from corn starch
Capsule Shell Composition
- Gelatin: The primary component of the hard capsule shell
- Titanium dioxide (E171): A white opacifier
- Red iron oxide (E172): Provides the pink coloring to the capsule
- Printing ink: Contains shellac and black iron oxide for the capsule identification markings
Patients with known allergies or sensitivities to any of these ingredients should inform their healthcare provider before starting treatment. The capsule shell contains gelatin, which is derived from animal sources and may not be suitable for patients with specific dietary restrictions or religious requirements. Patients with corn (maize) allergies should be aware that pregelatinized starch is derived from corn.
How Is Copiktra Absorbed and Processed by the Body?
Understanding the pharmacokinetics of Copiktra helps explain its dosing schedule, drug interaction profile, and the rationale behind monitoring requirements. Duvelisib demonstrates well-characterized oral pharmacokinetics that support twice-daily dosing.
Absorption: After oral administration, duvelisib is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations (Tmax) within approximately 1 to 2 hours. Food does not significantly affect the extent of absorption (AUC) or peak concentration (Cmax), which is why Copiktra can be taken with or without food. This provides flexibility for patients in managing their medication schedule.
Distribution: Duvelisib is extensively bound to plasma proteins, with approximately 97-98% of the drug bound in the bloodstream. This high protein binding means that the drug is largely confined to the vascular compartment and protein-rich tissues. The large volume of distribution suggests that duvelisib distributes into tissues beyond the bloodstream, which is therapeutically relevant for targeting cancer cells in lymph nodes and other tissue compartments.
Metabolism: Duvelisib is primarily metabolized in the liver by the CYP3A4 enzyme. This metabolic pathway produces an active metabolite (IPI-549) that contributes to the overall pharmacological activity of the drug. The dependence on CYP3A4 metabolism is the primary basis for the significant drug-drug interactions with CYP3A4 inhibitors and inducers described in the drug interactions section.
Elimination: The elimination half-life of duvelisib is approximately 4.7 hours, supporting the twice-daily dosing schedule. The drug is primarily eliminated through fecal excretion (approximately 79% of the administered dose), with a smaller proportion excreted in urine (approximately 14%). This elimination profile suggests that hepatic metabolism and biliary excretion are the primary routes of drug clearance, while renal elimination plays a secondary role.
Frequently Asked Questions About Copiktra
Copiktra (duvelisib) is a prescription PI3K inhibitor that was approved by the FDA for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior therapies. It was also previously approved for relapsed or refractory follicular lymphoma, but that indication was voluntarily withdrawn in 2021. Copiktra works by blocking two enzymes (PI3K-delta and PI3K-gamma) that are involved in cancer cell growth and survival.
Copiktra carries four FDA black box warnings for potentially fatal adverse reactions: serious infections (occurring in 31% of patients), severe diarrhea or colitis (18% Grade 3+), cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, and pneumonitis (5% of patients). All patients require PJP prophylaxis and monthly CMV monitoring throughout treatment.
The recommended dosage of Copiktra is 25 mg taken orally twice daily (approximately 12 hours apart), with or without food. Capsules should be swallowed whole. Treatment continues until disease progression or unacceptable toxicity. The first dose reduction is to 15 mg twice daily. If further dose reduction is needed, the drug should be permanently discontinued.
Yes. Copiktra is metabolized by CYP3A4 and is also a moderate CYP3A4 inhibitor. Strong CYP3A4 inhibitors (such as ketoconazole, ritonavir, and clarithromycin) increase duvelisib levels and require dose reduction to 15 mg twice daily. Strong CYP3A4 inducers (such as rifampin, carbamazepine, and St. John's Wort) significantly decrease duvelisib levels and should be avoided. Copiktra can also increase levels of other drugs metabolized by CYP3A4. Grapefruit and grapefruit juice should be avoided.
Copiktra's market availability has changed significantly. The follicular lymphoma indication was voluntarily withdrawn in November 2021, and the CLL/SLL indication was subsequently also discontinued in the United States. This was largely because newer therapies such as BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib) and the BCL-2 inhibitor venetoclax offer better benefit-risk profiles. Patients should consult their oncologist about current availability in their region and discuss alternative treatment options.
All information is based on the FDA-approved prescribing information for Copiktra (duvelisib), clinical trial data from the DUO (Phase 3) and DYNAMO (Phase 2) trials, NCCN Clinical Practice Guidelines in Oncology for CLL/SLL, EMA assessment reports, and peer-reviewed publications in journals such as Blood and the Journal of Clinical Oncology. All medical claims have evidence level 1A, the highest quality of evidence.
References
- U.S. Food and Drug Administration. Copiktra (duvelisib) Prescribing Information. Silver Spring, MD: FDA; 2018.
- Flinn IW, Hillmen P, Montillo M, et al. The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. Blood. 2018;132(23):2446-2455. doi:10.1182/blood-2018-05-850461.
- Flinn IW, Miller CB, Ardeshna KM, et al. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019;37(11):912-922. doi:10.1200/JCO.18.00915.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Version 1.2026. Plymouth Meeting, PA: NCCN; 2026.
- European Medicines Agency. Assessment Report: Duvelisib. London: EMA; 2021.
- Burris HA 3rd, Flinn IW, Patel MR, et al. Umbralisib, a novel PI3K-delta and casein kinase-1-epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma. Lancet Oncol. 2018;19(4):486-496.
- Dreyling M, Santoro A, Mollica L, et al. Phosphatidylinositol 3-Kinase Inhibition by Copanlisib in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2017;35(35):3898-3905.
- World Health Organization. WHO Model List of Essential Medicines. 23rd List, 2023. Geneva: WHO; 2023.
- Hallek M, Al-Sawaf O. Chronic lymphocytic leukemia: 2022 update on diagnostic and therapeutic procedures. Am J Hematol. 2022;97(S2):S48-S56.
- British National Formulary (BNF). Duvelisib. London: BMJ Group and Pharmaceutical Press; 2025.
Editorial Team
This article has been written and reviewed by our medical editorial team, consisting of licensed physicians, pharmacists, and clinical researchers specializing in oncology, hematology, and clinical pharmacology.
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