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Imbruvica

Generic Name: Ibrutinib
Class: Antineoplastic Agents
Chemical Name: 1 - [(3R) - 3 - [4 - Amino - 3 - (4 - phenoxyphenyl) - 1H - pyrazolo[3,4 - d]pyrimidin - 1 - yl] - 1 - piperidinyl] - 2 - propen - 1 - one
Molecular Formula: C25H24N6O2
CAS Number: 936563-96-1

Introduction

Antineoplastic agent; inhibitor of Bruton's tyrosine kinase (BTK).1 4 5 6 7

Uses for Imbruvica

Mantle Cell Lymphoma

Treatment of mantle cell lymphoma in patients who have received at least one prior therapy; designated an orphan drug by FDA for this use.1 9

Current indication based on overall response rate; improvement in patient-reported outcomes and overall survival not established.1

Continued FDA approval for this indication may be contingent on confirmation of clinical benefit in additional trials.1

Chronic Lymphocytic Leukemia (CLL)

Treatment of CLL in patients who have received at least one prior therapy; designated an orphan drug by FDA for this use.1 3 9 16

Treatment of CLL in patients who harbor the 17p13.1 deletion (17p deletion) chromosomal abnormality (including treatment-naive patients); designated an orphan drug by FDA for this use.1 9 16 17 18 20 21 22

Waldenstrom Macroglobulinemia

Treatment of Waldenstrom macroglobulinemia; designated an orphan drug by FDA for this use.1 9 15 19

Imbruvica Dosage and Administration

Administration

Oral Administration

Administer orally once daily at approximately the same time each day.1

Swallow capsules whole with water; do not open, break, or chew.1

Dosage

Adults

Mantle Cell Lymphoma
Oral

560 mg once daily.1 In the principal clinical trial, therapy was continued for as long as the patient derived clinical benefit or until unacceptable toxicity occurred.1 2

CLL
Oral

420 mg once daily.1 In the principal clinical trial, therapy was continued for as long as the patient derived clinical benefit or until unacceptable toxicity occurred.1

Waldenstrom Macroglobulinemia
Oral

420 mg once daily.1 In the principal clinical trial, therapy was continued for as long as the patient derived clinical benefit or until unacceptable toxicity occurred.1 19

Dosage adjustment not necessary in patients undergoing plasmapheresis.1

Dosage Modification for Toxicity

If ≥ grade 3 nonhematologic toxicity, ≥ grade 3 neutropenia with infection or fever, or grade 4 hematologic toxicity occurs, interrupt therapy.1 Following recovery from toxicity (i.e., return to baseline or resolution to grade 1), resume (or discontinue) therapy as described in Table 1.1

Table 1: Dosage Modifications for Ibrutinib Toxicity

Dosage Modification after Recovery from Toxicity

Toxicity Occurrence

Mantle Cell Lymphoma (Starting Dosage = 560 mg daily)

CLL and Waldenstrom Macroglobulinemia (Starting Dosage = 420 mg daily)

First

Restart at 560 mg daily

Restart at 420 mg daily

Second

Restart at 420 mg daily

Restart at 280 mg daily

Third

Restart at 280 mg daily

Restart at 140 mg daily

Fourth

Discontinue ibrutinib

Discontinue ibrutinib

Concomitant Use with Drugs or Foods Affecting Hepatic Microsomal Enzymes

Avoid concomitant use with potent or moderate inhibitors of CYP3A; if concomitant use of a moderate CYP3A inhibitor cannot be avoided, reduce ibrutinib dosage to 140 mg once daily.1 14 (See Interactions.)

Special Populations

Hepatic Impairment

Mild (Child-Pugh class A) hepatic impairment: Reduce dosage to 140 mg once daily.1 Monitor for signs of toxicity.1 (See Hepatic Impairment under Cautions.)

Moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment: Avoid use.1

Renal Impairment

No specific dosage recommendations at this time.1 (See Renal Impairment under Cautions.)

Geriatric Patients

No specific dosage recommendations at this time; however, certain ibrutinib toxicities may be more frequent in geriatric patients.1 (See Geriatric Use under Cautions.)

Cautions for Imbruvica

Contraindications

  • Manufacturer states none known.1

Warnings/Precautions

Hemorrhage

Hemorrhagic events, sometimes fatal, observed.1 2 3 11 16 Serious (grade 3 or higher) bleeding events, including subdural hematoma, GI bleeding, hematuria, and postprocedural hemorrhage, observed.1 2 3 11 16

Increased risk of hemorrhagic events with concomitant use of ibrutinib and antiplatelet or anticoagulant therapies.1

Consider potential benefits and risks of withholding ibrutinib therapy for at least 3–7 days prior to and following surgery.1

Infectious Complications

Serious infections, sometimes fatal, observed.1 16

Progressive leukoencephalopathy (PML) also observed.1

Myelosuppression

Cytopenias, including thrombocytopenia, anemia, and neutropenia, observed.1 Serious (grade 3 or 4) cytopenias observed.1

Monitor CBC counts monthly.1 If myelosuppression occurs, reduce dosage or interrupt therapy.1 (See Dosage Modification for Toxicity under Dosage and Administration.)

Atrial Fibrillation

Atrial fibrillation and atrial flutter observed.1 16

Increased risk of atrial fibrillation in patients with cardiac risk factors, acute infections, or history of atrial fibrillation.1 16

Monitor for development of atrial fibrillation.1 If symptoms of arrhythmia (e.g., palpitations, lightheadedness) or new-onset dyspnea occur, monitor ECG.1 If atrial fibrillation persists, consider reducing dosage and carefully weigh potential benefit of drug against risks of continued therapy.1

Development of Second Primary Malignancy

Development of other malignancies, including non-skin carcinomas, reported in 5–14% of ibrutinib-treated patients.1 Non-melanoma skin cancer occurred in 4–11% of ibrutinib-treated patients.1

Tumor Lysis Syndrome

Tumor lysis syndrome reported.1

Increased risk in patients with large tumor burden; closely monitor such patients and take appropriate precautions.1

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; embryofetal toxicity and teratogenicity demonstrated in animals.1 Avoid pregnancy during therapy.1 If used during pregnancy or if patient becomes pregnant while receiving drug, apprise of potential fetal hazard.1

Renal Toxicity

Serious, sometimes fatal, renal failure reported.1 Scr of 1.5–3 times ULN observed in ibrutinib-treated patients with mantle cell lymphoma.1

Specific Populations

Pregnancy

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether ibrutinib is distributed into milk.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

In the principal clinical trial in patients with mantle cell lymphoma, no difference in efficacy in geriatric patients (≥65 years of age) compared with younger adults, but toxicity (i.e., atrial fibrillation, hypertension, pneumonia, cellulitis, diarrhea, dehydration) occurred more frequently in geriatric patients.1

In the principal phase 3 clinical trial in patients with CLL, no difference in efficacy in geriatric patients (≥65 years of age) compared with younger adults, but grade 3 or higher toxicity occurred more frequently in geriatric patients.1

In the principal clinical trial in patients with Waldenstrom macroglobulinemia, no overall differences in efficacy in geriatric patients (≥65 years of age) compared with younger adults, but some toxicities (i.e., atrial fibrillation, hypertension, pneumonia, urinary tract infection) occurred more frequently in geriatric patients.1

Hepatic Impairment

Safety not established.1

Increased systemic exposure and peak plasma concentrations in patients with mild to severe hepatic impairment.1 (See Absorption: Special Populations, under Pharmacokinetics.)

Adjust dosage as appropriate and monitor for toxicity if used in patients with mild hepatic impairment.1 (See Special Populations under Dosage and Administration.)

Avoid use in patients with moderate or severe hepatic impairment.1

Renal Impairment

Systemic exposure apparently not affected in patients with Clcr >25 mL/minute.1

No experience in patients with severe renal impairment (Clcr <25 mL/minute) or in those undergoing dialysis.1

Common Adverse Effects

Previously treated mantle cell lymphoma: Thrombocytopenia,1 diarrhea,1 2 neutropenia,1 anemia,1 fatigue,1 2 musculoskeletal pain,1 peripheral edema,1 2 upper respiratory tract infection,1 2 nausea,1 2 bruising,1 dyspnea,1 2 constipation,1 2 rash,1 abdominal pain,1 vomiting,1 2 decreased appetite.1 2

CLL: Thrombocytopenia,1 16 neutropenia,1 16 diarrhea,1 16 anemia,1 16 fatigue,1 16 musculoskeletal pain,1 upper respiratory tract infection,1 rash,1 nausea,1 16 pyrexia.1 16

Waldenstrom macroglobulinemia: Neutropenia,1 thrombocytopenia,1 diarrhea,1 rash,1 nausea,1 muscle spasms,1 fatigue.1

Interactions for Imbruvica

Principally metabolized by CYP3A and, to a lesser extent, by CYP2D6 to an active dihydrodiol metabolite (PCI-45227).1

Ibrutinib and PCI-45227 do not inhibit major CYP isoenzymes at clinically relevant concentrations in vitro, but are weak inducers of CYP isoenzymes.1

Ibrutinib not a substrate of P-glycoprotein (P-gp) in vitro; not expected to inhibit P-gp substrates at clinically relevant concentrations.1

CYP3A Inhibitors

Possible pharmacokinetic interaction (increased serum ibrutinib concentrations).1 Moderate CYP3A inhibitors may increase AUC of ibrutinib by fivefold to eightfold.1 Larger increases in AUC and peak plasma concentrations (e.g., by 24- and 29-fold, respectively) possible with potent CYP3A inhibitors.1 (See Specific Drugs and Foods under Interactions.)

Avoid concomitant use with moderate or potent CYP3A inhibitors; consider an alternative agent with no or minimal enzyme inhibition potential.1

If concomitant use with a moderate CYP3A inhibitor cannot be avoided, reduce ibrutinib dosage to 140 mg daily.1 14

If short-term (≤7 days) administration of a potent CYP3A inhibitor is required, withhold ibrutinib during such administration.1

Closely monitor patient for adverse effects if concomitant use of a CYP3A inhibitor cannot be avoided.1

CYP3A Inducers

Possible pharmacokinetic interaction (decreased serum ibrutinib concentrations).1 Potent inducers of CYP3A may reduce peak plasma concentration and AUC of ibrutinib by >10-fold.1 Moderate CYP3A inducers may reduce ibrutinib AUC by up to threefold.1

Avoid concomitant use; select alternative agent with no or minimal enzyme induction potential.1 (See Specific Drugs and Foods under Interactions.)

Substrates of P-gp Transport Systems

Possible pharmacokinetic interaction (increased plasma P-gp substrate concentrations).1 (See Specific Drugs and Foods under Interactions.)

Specific Drugs and Foods

Drug or Food

Interaction

Comments

Anticoagulants

Increased risk of hemorrhagic events1

Anticonvulsants (carbamazepine, phenytoin)

Possibly decreased peak plasma concentration and AUC of ibrutinib by >10-fold1

Avoid concomitant use; select alternative drug with no or minimal CYP3A induction potential1

Antifungals, azole (e.g., fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole)

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Ketoconazole: increased ibrutinib peak plasma concentration and AUC by 29- and 24-fold, respectively1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, closely monitor patient for adverse effects1

Itraconazole, ketoconazole, posaconazole, voriconazole: If concomitant use of the antifungal is short term (≤7 days), withhold ibrutinib therapy during administration of the antifungal1

Fluconazole: If concomitant use cannot be avoided, reduce ibrutinib dosage to 140 mg once daily1 14

Antimycobacterials, rifamycins (e.g., rifampin)

Rifampin, a potent CYP3A inducer, decreased ibrutinib peak plasma concentration and AUC by 13- and 10-fold, respectively1

Moderate CYP3A inducers: Possibly decreased AUC of ibrutinib by up to threefold1

Avoid concomitant use with potent CYP3A inducers; select alternative drug with no or minimal CYP3A induction potential1

Antiplatelet agents

Increased risk of hemorrhagic events1

Antiretroviral agents, HIV protease inhibitors (e.g., atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir)

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, closely monitor patient for adverse effects1

If antiretroviral is a moderate CYP3A inhibitor and concomitant use cannot be avoided, reduce ibrutinib dosage to 140 mg once daily1 14

Antiretroviral agents, nonnucleoside reverse transcriptase inhibitors (e.g., efavirenz)

Potent CYP3A inducers: Possibly decreased peak plasma concentration and AUC of ibrutinib by >10-fold1

Moderate CYP3A inducers: Possibly decreased AUC of ibrutinib by up to threefold1

Avoid concomitant use with potent CYP3A inducers; select alternative drug with no or minimal CYP3A induction potential1

Aprepitant

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, reduce ibrutinib dosage to 140 mg once daily and closely monitor patient for adverse effects1 14

Calcium-channel blockers (diltiazem, verapamil)

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, reduce ibrutinib dosage to 140 mg once daily and closely monitor patient for adverse effects1 14

Ciprofloxacin

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, reduce ibrutinib dosage to 140 mg once daily and closely monitor patient for adverse effects1 14

Crizotinib

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, reduce ibrutinib dosage to 140 mg once daily and closely monitor patient for adverse effects1 14

Digoxin

Because concentrations of ibrutinib are higher in the GI tract following oral administration, concentrations of oral drugs that are substrates of P-gp may be increased1

Grapefruit or grapefruit juice

Grapefruit products moderately inhibit CYP3A; possibly increased ibrutinib concentrations1

Avoid concomitant use

Imatinib

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, reduce ibrutinib dosage to 140 mg once daily and closely monitor patient for adverse effects1 14

Macrolides (clarithromycin, erythromycin, telithromycin)

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, closely monitor patient for adverse effects1

Clarithromycin, telithromycin: If concomitant use of the macrolide is short term (≤7 days), withhold ibrutinib therapy during administration of the macrolide1

Erythromycin: If concomitant use cannot be avoided, reduce ibrutinib dosage to 140 mg once daily 1 14

Nefazodone

Possibly increased peak plasma concentration and systemic exposure of ibrutinib1

Avoid concomitant use; select alternative drug with no or minimal CYP3A inhibition potential1

If concomitant use cannot be avoided, closely monitor patient for adverse effects1

Seville oranges or Seville orange juice

Seville orange products moderately inhibit CYP3A; possibly increased ibrutinib concentrations1

Avoid concomitant use

St. John’s wort (Hypericum perforatum)

Potent CYP3A inducers: Possibly decreased peak plasma concentration and AUC of ibrutinib by >10-fold1

Avoid concomitant use; select alternative drug with no or minimal CYP3A induction potential1

Imbruvica Pharmacokinetics

Absorption

Food

Oral administration with food increases peak plasma concentration by twofold to fourfold and systemic exposure by twofold, compared with administration following overnight fasting.1

Special Populations

Patients with mild hepatic impairment (Child-Pugh class A): Peak plasma concentration or systemic exposure increased by 5.2- or 2.7-fold, respectively.1

Patients with moderate hepatic impairment (Child-Pugh class B): Peak plasma concentration or systemic exposure increased by 8.8- or 8.2-fold, respectively.1

Patients with severe hepatic impairment (Child-Pugh class C): Peak plasma concentration or systemic exposure increased by 7- or 9.8-fold, respectively.1

Systemic exposure apparently not affected in patients with Clcr >25 mL/minute.1

Distribution

Extent

Extensive tissue distribution; not known whether distributed into milk.1

Plasma Protein Binding

97.3%.1

Elimination

Metabolism

Metabolized principally by CYP3A and, to a lesser extent, by CYP2D6 to the active dihydrodiol metabolite PCI-45227.1

Elimination Route

Eliminated in feces (80%) and urine (<10%).1

Half-life

4–6 hours.1

Special Populations

Age (range: 37–84 years) and gender do not substantially affect pharmacokinetics of ibrutinib.1

Stability

Storage

Oral

Capsules

20–25°C (may be exposed to 15–30°C).1

Actions

  • Selectively and irreversibly inhibits BTK, resulting in inhibition of downstream effector activity within the B-cell antigen receptor (BCR) signaling pathway.1 4 5 6 7

  • Inhibits other receptor kinases (e.g., Bmx/Etk, EGFR, Hck, Yes) in vitro.8

  • Inhibits proliferation and survival of malignant B-cells in vivo.1

  • Demonstrates cell migration and substrate adhesion of CLL cells and mantle cell lymphoma cells in vitro;1 2 mobilization of cells from tissues to peripheral blood results in a transient increase in absolute lymphocyte count in peripheral blood.2 12 13

  • Demonstrates substantial activity in activated B-cell-like diffuse B-cell non-Hodgkin's lymphoma (ABC-DLBCL) cells expressing wild-type caspase recruitment domain-containing protein-11 (wild-type CARD-11) in vitro and in vivo.5 6

Advice to Patients

  • Importance of advising patients to take ibrutinib as directed by their clinician and at approximately the same time each day.1 If a dose is missed, importance of administering the missed dose on the same day as soon as it is remembered.1 Patients should be advised not to take 2 doses on the same day to make up for a missed dose.1

  • Importance of advising patients to swallow ibrutinib capsules whole with a glass of water and not to open, break, or chew the capsules.1

  • Risk of bleeding.1 Importance of promptly informing clinician of any episodes of unusual bleeding (e.g., blood in stool or urine, prolonged or uncontrolled bleeding).1 Importance of notifying clinician before any planned surgeries, including dental procedures.1

  • Risk of serious infection.1 Importance of reporting signs or symptoms of possible infection (e.g., chills, fever).1

  • Risk of atrial fibrillation.1 Importance of informing clinician if palpitations, lightheadedness, dizziness, fainting, shortness of breath, or chest discomfort occurs.1

  • Risk of nephrotoxicity.1

  • Possible risk of developing a second primary malignancy (e.g., skin cancer).1

  • Risk of tumor lysis syndrome.1 Importance of reporting signs or symptoms of tumor lysis syndrome (e.g., arrhythmia, seizure).1

  • Risk of fetal harm.1 Apprise patient of potential hazard to the fetus if used during pregnancy; women of childbearing potential should avoid becoming pregnant.1

  • Risk of diarrhea.1 Importance of advising patients to maintain adequate hydration during ibrutinib therapy.1 Importance of informing clinician if diarrhea persists.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements (e.g., St. John’s wort), as well as any concomitant illnesses.1 Importance of advising patients not to consume grapefruit or Seville oranges.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ibrutinib

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

140 mg

Imbruvica

Pharmacyclics (comarketed by Janssen Biotech)

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814. Review Date: September 06, 2016.

References

1. Pharmacyclics, Inc. and Janssen Biotech, Inc. Imbruvica (ibrutinib) capsules prescribing information. Sunnyvale, CA; 2015 Jan.

2. Wang ML, Rule S, Martin P et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013; 369:507-16. [PubMed 23782157]

3. Byrd JC, Furman RR, Coutre SE et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013; 369:32-42. [PubMed 23782158]

4. Advani RH, Buggy JJ, Sharman JP et al. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol. 2013; 31:88-94. [PubMed 23045577]

5. Dasmahapatra G, Patel H, Dent P et al. The Bruton tyrosine kinase (BTK) inhibitor PCI-32765 synergistically increases proteasome inhibitor activity in diffuse large-B cell lymphoma (DLBCL) and mantle cell lymphoma (MCL) cells sensitive or resistant to bortezomib. Br J Haematol. 2013; 161:43-56. [PubMed 23360303]

6. Chavez JC, Sahakian E, Pinilla-Ibarz J. Ibrutinib: an evidence-based review of its potential in the treatment of advanced chronic lymphocytic leukemia. Core Evid. 2013; 8:37-45. [PubMed 23717217]

7. Dias AL, Jain D. Ibrutinib: A New Frontier in the Treatment of Chronic Lymphocytic Leukemia by Bruton's Tyrosine Kinase Inhibition. Cardiovasc Hematol Agents Med Chem. 2013; 11:265-71. [PubMed 24433470]

8. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number 205552Orig1s000: Pharmacology review(s). From FDA website.

9. US Food and Drug Administration. Search orphan drug designations and approvals. From FDA website. Accessed 2014 May 21.

10. Woyach JA, Johnson AJ, Byrd JC. The B-cell receptor signaling pathway as a therapeutic target in CLL. Blood. 2012; 120:1175-84. [PubMed 22715122]

11. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number 205552Orig1s000: Summary review. From FDA website.

12. Rossi D, Gaidano G. Lymphocytosis and ibrutinib treatment of CLL. Blood. 2014; 123:1772-4. [PubMed 24652958]

13. Herman SE, Niemann CU, Farooqui M et al. Ibrutinib-induced lymphocytosis in patients with chronic lymphocytic leukemia: correlative analyses from a phase II study. Leukemia. 2014; :. [PubMed 24699307]

14. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number 205552Orig1s000: Clinical pharmacology and biopharmaceutics review(s). From FDA website.

15. Pharmacyclics, Sunnyvale, CA: Personal communication.

16. Byrd JC, Brown JR, O'Brien S et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014; 371:213-23. [PubMed 24881631]

17. Farooqui MZ, Valdez J, Martyr S et al. Ibrutinib for previously untreated and relapsed or refractory chronic lymphocytic leukaemia with TP53 aberrations: a phase 2, single-arm trial. Lancet Oncol. 2015 Feb; 16:169-76.

18. Byrd JC, Furman RR, Coutre S et al. The bruton's tyrosine kinase (BTK) inhibitor ibrutinib (PCI-32765) promotes high response rate, durable remissions, and is tolerable in treatment naive (TN) and relapsed or refractory (RR) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients including patients with high-risk (HR) disease: New and updated results of 116 patients in a phase Ib/II study. Blood. 2012; 120(21):189. Abstract.

19. Treon SP, Tripsas CK, Meid K et al. Ibrutinib in previously treated Waldenström’s macroglobulinemia. N Engl J Med. 2015; 372:1430-40.

20. Farooqui M, Aue G, Valdez J et al. Single agent ibrutinib (PCI-32765) achieves equally good and durable responses in chronic lymphocytic leukemia (CLL) patients with and without deletion 17p. Oral presentation at the 55th Annual Meeting of the American Society of Hematology, New Orleans, LA, 2012 Dec 7-10.

21. Wiestner A, Farooqui M, Valdez J, et al. Single agent ibrutinib (PCI-32765) is highly effective in chronic lymphocytic leukaemia patients with 17p deletion. Hematol Oncol. 2013; 31:96-150.

22. O'Brien SM, Furman RR, Coutre SE et al. Independent evaluation of ibrutinib efficacy 3 years post-initiation of monotherapy in patients with chronic lymphocytic leukemia/small lymphocytic leukemia including deletion 17p disease. J Clin Oncol. 2014; 32:5s (American Society of Clinical Oncology Annual Meeting Abstracts):Abstract No. 7014.

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