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Zydelig

Generic Name: Idelalisib
Class: Antineoplastic Agents
Chemical Name: 5-Fluoro-3-phenyl-2-[(1S)-1-(9H-purin-6-ylamino)propyl]-(3H)-quinazolinone
Molecular Formula: C22H18FN7O
CAS Number: 870281-82-6

Warning(s)

  • Hepatotoxicity
  • Serious and/or fatal hepatotoxicity reported.1 Monitor serum ALT and AST concentrations prior to initiating therapy and periodically thereafter.1 If hepatotoxicity occurs, may need to interrupt therapy, reduce dosage, and/or permanently discontinue idelalisib depending on severity of hepatotoxicity.1 (See Hepatotoxicity under Dosage and Administration and also see Hepatotoxicity under Cautions.)

  • GI Effects
  • Severe (≥grade 3) diarrhea or colitis reported.1 Monitor for development of severe diarrhea or colitis.1 If moderate or severe diarrhea occurs, may need to interrupt therapy, reduce dosage, and/or permanently discontinue idelalisib depending on severity of diarrhea.1 (See Diarrhea under Dosage and Administration and also see Diarrhea or Colitis under Cautions.)

  • Severe and fatal intestinal perforation reported.1 If intestinal perforation occurs, permanently discontinue idelalisib.1 (See Intestinal Perforation under Cautions.)

  • Pneumonitis
  • Serious or fatal pneumonitis reported.1 Evaluate patients for possible pneumonitis if pulmonary manifestations (e.g., cough, dyspnea, hypoxia, interstitial infiltrates on radiologic exam, >5% decrease in oxygen saturation) occur.1 If pneumonitis is suspected, interrupt or discontinue therapy.1 (See Pneumonitis under Cautions.)

REMS:

FDA approved a REMS for idelalisib to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of idelalisib and consists of the following: communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antineoplastic agent; an inhibitor of phosphoinositide 3-kinase isoform delta (PI3Kδ).1 6 7 8 9 10

Uses for Zydelig

Chronic Lymphocytic Leukemia (CLL)

Used in combination with rituximab for treatment of relapsed CLL in patients in whom monotherapy with rituximab would be considered appropriate therapy due to other comorbidities (designated an orphan drug by FDA for this use).1 2 3

Follicular B-cell Non-Hodgkin's Lymphoma (NHL)

Treatment of relapsed follicular B-cell NHL in patients who previously received ≥2 systemic therapies (designated an orphan drug by FDA for this use).1 3 4

Efficacy based on overall response rate; clinical benefit (e.g., improvement in survival, amelioration of disease-related symptoms) not established.1

Small Lymphocytic Lymphoma (SLL)

Treatment of relapsed SLL in patients who previously received ≥2 systemic therapies (designated an orphan drug by FDA for this use).1 3

Efficacy based on overall response rate; clinical benefit (e.g., improvement in survival, amelioration of disease-related symptoms) not established.1

Zydelig Dosage and Administration

General

  • Monitor liver function tests prior to initiation of therapy, every 2 weeks during the first 3 months of therapy, every 4 weeks during the next 3 months, and then every 1–3 months thereafter.1 More frequent monitoring recommended in patients who develop elevated ALT, AST, or bilirubin concentrations during therapy.1 (See Hepatotoxicity under Dosage and Administration.)

  • Monitor CBC at least every 2 weeks during the first 3 months of therapy.1 More frequent monitoring recommended in patients who develop myelosuppression during therapy.1 (See Myelosuppression under Dosage and Administration.)

  • Because idelalisib may cause hepatotoxicity or severe diarrhea, avoid concomitant use with drugs that may cause hepatotoxicity or diarrhea.1 (See Hepatotoxicity and also Diarrhea or Colitis under Cautions.)

Administration

Oral Administration

Administer orally twice daily without regard to meals.1 Swallow tablets whole.1

Dosage

Adults

CLL
Relapsed CLL
Oral

150 mg twice daily in combination with rituximab.1 Continue therapy until disease progression or unacceptable toxicity occurs.1 Manufacturer states safety and efficacy of use beyond several months not established; in phase 3 study, median duration of exposure to idelalisib was 5 months.1

Follicular B-cell NHL
Relapsed Follicular B-cell NHL Following Failure of ≥2 Prior Systemic Therapies
Oral

150 mg twice daily.1 Continue therapy until disease progression or unacceptable toxicity occurs.1 Manufacturer states safety and efficacy of use beyond several months not established; in single-arm study, median duration of exposure to idelalisib was 6.1 months.1

SLL
Relapsed SLL Following Failure of ≥2 Prior Systemic Therapies
Oral

150 mg twice daily.1 Continue therapy until disease progression or unacceptable toxicity occurs.1 Manufacturer states safety and efficacy of use beyond several months not established.1

Dosage Modification for Toxicity

May need to interrupt therapy, reduce dosage, and/or permanently discontinue idelalisib if severe hepatotoxicity, diarrhea, or myelosuppression occurs.1

If other severe or life-threatening toxicities occur, withhold idelalisib until toxicity resolves.1 If clinically appropriate, resume therapy at reduced dosage of 100 mg twice daily.1 If severe or life-threatening toxicities recur at dosage of 100 mg twice daily, permanently discontinue idelalisib.1

Hepatotoxicity

If ALT and/or AST concentrations increase to >3–5 times the ULN or bilirubin concentrations increase to >1.5–3 times the ULN, continue idelalisib at the same dosage; monitor liver function tests at least weekly until ALT, AST, and bilirubin concentrations return to within normal limits.1

If ALT and/or AST concentrations increase to >5–20 times the ULN or bilirubin concentrations increase to >3–10 times the ULN, withhold idelalisib; monitor liver function tests at least weekly.1 When ALT, AST, and bilirubin concentrations return to within normal limits, resume therapy at reduced dosage of 100 mg twice daily.1

If ALT and/or AST concentrations increase to >20 times the ULN or bilirubin concentrations increase to >10 times ULN, permanently discontinue idelalisib.1

Diarrhea

If moderate diarrhea (4–6 stools per day over baseline) occurs, continue idelalisib at the same dosage and monitor patient at least weekly until diarrhea resolves.1

If severe diarrhea (≥7 stools per day over baseline) or diarrhea requiring hospitalization occurs, withhold idelalisib and monitor patient at least weekly; when diarrhea resolves, resume therapy at reduced dosage of 100 mg twice daily.1

If life-threatening diarrhea occurs, permanently discontinue idelalisib.1

Myelosuppression

If ANC is 1000 to <1500/mm3 or platelet count is 50,000 to <75,000/mm3, continue idelalisib at the same dosage.1

If ANC is 500 to <1000/mm3 or platelet count is 25,000 to <50,000/mm3, continue idelalisib at the same dosage; monitor ANC and platelet count at least weekly.1

If ANC is <500/mm3 or platelet count is <25,000/mm3, withhold idelalisib; monitor ANC and platelet count at least weekly.1 When ANC is ≥500/mm3 and platelet count is ≥25,000/mm3, resume therapy at reduced dosage of 100 mg twice daily.1

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time; however, monitor for signs of toxicity and adjust dosage as appropriate.1 (See Hepatotoxicity under Dosage and Administration and also see Hepatic Impairment under Cautions.)

Renal Impairment

Clcr ≥15 mL/minute: No dosage adjustment needed.1 (See Renal Impairment under Cautions.)

Geriatric Patients

No specific dosage recommendations at this time.1 (See Geriatric Use under Cautions.)

Cautions for Zydelig

Contraindications

  • History of serious hypersensitivity reactions, including anaphylaxis and toxic epidermal necrolysis.1

Warnings/Precautions

Warnings

Hepatotoxicity

Serious and/or fatal hepatotoxicity reported.1

ALT or AST elevations of >5 times the ULN reported; elevations generally occurred during initial 12 weeks of therapy.1 ALT or AST elevations reversible following temporary interruption of therapy; however, recurrence reported in 26% of patients following resumption of idelalisib therapy at reduced dosage.1

Monitor serum ALT and AST concentrations at baseline, every 2 weeks during the first 3 months of therapy, every 4 weeks during the next 3 months, and then every 1–3 months thereafter.1 If hepatotoxicity occurs, monitor liver function tests more frequently until levels return to within normal limits.1 May need to interrupt therapy, reduce dosage, and/or permanently discontinue idelalisib depending on severity of hepatotoxicity.1 (See Hepatotoxicity under Dosage and Administration.)

Discontinue therapy if hepatotoxicity recurs.1

Avoid concomitant use with drugs that may cause hepatotoxicity.1

Diarrhea or Colitis

Severe (≥grade 3) diarrhea or colitis reported.1

Diarrhea can occur at any time and responds poorly to antimotility agents.1

Diarrhea resolves within a median of 1 week to 1 month following temporary interruption of therapy and, in some instances, use of corticosteroids.1

Monitor for development of severe diarrhea or colitis.1 If moderate or severe diarrhea occurs, monitor patients at least weekly until diarrhea resolves.1 May need to interrupt therapy, reduce dosage, and/or permanently discontinue idelalisib depending on severity of diarrhea.1 (See Diarrhea under Dosage and Administration.) If life-threatening diarrhea occurs, permanently discontinue idelalisib.1

Avoid concomitant use with drugs that may cause diarrhea.1

Intestinal Perforation

Severe and fatal intestinal perforation reported.1 At the time of perforation, some patients had moderate to severe diarrhea.1

If intestinal perforation occurs, permanently discontinue idelalisib.1 (See Advice to Patients.)

Pneumonitis

Serious or fatal pneumonitis reported.1

Evaluate patients for possible pneumonitis if pulmonary manifestations (e.g., cough, dyspnea, hypoxia, interstitial infiltrates on radiologic exam, >5% decrease in oxygen saturation) occur.1 If pneumonitis is suspected, withhold therapy until etiology of pulmonary symptoms has been determined.1

Treatment for idelalisib-induced pneumonitis has included discontinuance of idelalisib and administration of corticosteroids.1

Sensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, reported.1 If severe hypersensitivity reaction occurs, permanently discontinue idelalisib and institute supportive treatment.1

Other Warnings and Precautions

Dermatologic Effects

Severe or life-threatening dermatologic reactions, including exfoliative dermatitis, rash (i.e., erythematous, generalized, macular, maculopapular, papular, pruritic, and exfoliative rash), and toxic skin reactions reported.1

Toxic epidermal necrolysis reported in at least one patient receiving idelalisib in combination with rituximab and bendamustine.1

Monitor patients for development of severe dermatologic reactions.1 If severe dermatologic reactions occur, discontinue idelalisib.1

Neutropenia

Severe (grade 3 or 4) neutropenia reported.1

Monitor CBC at least every 2 weeks during the first 3 months of therapy.1 If neutropenia occurs, monitor CBC more frequently.1 May need to interrupt therapy and reduce dosage depending on severity of neutropenia.1 (See Myelosuppression under Dosage and Administration.)

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.1 Teratogenicity and embryofetal toxicity demonstrated in animals receiving dosages equivalent to 12–30 times human exposure.1 Avoid pregnancy during therapy and for ≥1 month after drug discontinuance.1 (See Advice to Patients.) If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1

Specific Populations

Pregnancy

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

Lactation

Not known whether distributed into milk; discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established in pediatric patients <18 years of age.1

Geriatric Use

No overall differences in efficacy in geriatric patients (≥65 years of age) compared with younger adults.1

Higher incidences of serious adverse reactions, death, or discontinuance of idelalisib due to adverse reactions observed in patients ≥65 years of age or older with CLL or NHL compared with younger adults.1

Hepatic Impairment

Increased systemic exposure in patients with elevated ALT, AST, or bilirubin concentrations.1 (See Special Populations under Pharmacokinetics.) Monitor for adverse effects.1 (See Hepatic Impairment under Dosage and Administration.)

Safety and efficacy not established in patients with baseline ALT or AST concentrations >2.5 times the ULN or bilirubin concentrations >1.5 times the ULN because these patients were excluded from clinical studies.1

Renal Impairment

Systemic exposure not affected by severe renal impairment (Clcr 15–29 mL/minute).1 (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Combination therapy with rituximab in patients with relapsed CLL: Pyrexia,1 2 nausea,1 pneumonia,1 diarrhea,1 2 chills,1 2 rash,1 2 vomiting,1 2 decreased appetite,2 night sweats,2 headache,1 sepsis,1 sinusitis,1 pain,1 arthralgia,1 gastroesophageal reflux disease (GERD),1 stomatitis,1 bronchitis,1 nasal congestion,1 urinary tract infection,1 neutropenia,1 2 hypertriglyceridemia,1 hyperglycemia,1 elevated aminotransferase (ALT or AST) and γ-glutamyltransferase ([gamma]-glutamyltranspeptidase, GGT, GGTP) concentrations,1 2 decreased or increased lymphocyte count,1 hyponatremia,1 hypoglycemia.1

Monotherapy in patients with indolent NHL: Diarrhea,1 fatigue,1 nausea,1 cough,1 pyrexia,1 abdominal pain,1 pneumonia,1 rash,1 dyspnea,1 decreased appetite,1 vomiting,1 asthenia,1 upper respiratory tract infection,1 night sweats,1 insomnia,1 headache,1 peripheral edema,1 neutropenia,1 elevated ALT or AST concentrations,1 decreased hemoglobin concentrations,1 thrombocytopenia.1

Metabolized by aldehyde oxidase, CYP3A and, to a lesser extent, UGT1A4.1

Idelalisib: Substrate of CYP3A, aldehyde oxidase, UGT1A4, P-glycoprotein (P-gp), and breast cancer resistance protein (BCRP).1 Inhibits CYP isoenzymes 2C8, 2C19 and 3A; also inhibits UGT1A1, P-gp, organic anion transport protein (OATP) 1B1, and OATP1B3.1 Induces CYP isoenzymes 2B6 and 3A4.1

Major metabolite (GS-563117): Substrate of P-gp and BCRP.1 Inhibits CYP isoenzymes 2C8, 2C9, 2C19, and 3A; also inhibits UGT1A1, OATP1B1, and OATP1B3.1

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A: Potential pharmacokinetic interaction (increased systemic exposure to idelalisib).1 Monitor for signs of toxicity; may need to interrupt therapy and reduce dosage if severe adverse effects occur.1 (See Specific Drugs under Interactions and also see Dosage Modification for Toxicity under Dosage and Administration.)

Potent inducers of CYP3A: Potential pharmacokinetic interaction (decreased systemic exposure to idelalisib).1 Avoid concomitant use.1 (See Specific Drugs under Interactions.)

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP3A: Potential pharmacokinetic interaction (increased systemic exposure of CYP3A substrate).1 Avoid concomitant use.1 (See Specific Drugs under Interactions.)

Drugs Affecting the P-glycoprotein Transport System

P-gp inducer: Potential pharmacokinetic interaction (decreased systemic exposure to idelalisib).1 Avoid concomitant use.1 (See Specific Drugs under Interactions.)

Substrates of P-glycoprotein or OATP Transport Systems

Substrates of hepatic uptake transport proteins OATP1B1 or OATP1B3: Pharmacokinetic interaction not observed to date.1

Substrates of P-gp: Pharmacokinetic interaction not observed to date.1

Specific Drugs

Drug

Interaction

Comments

Anticonvulsants (carbamazepine, phenytoin)

Possible decreased systemic exposure to idelalisib1

Avoid concomitant use1

Digoxin

No effect on systemic exposure to digoxin1 14

Ketoconazole

Increased AUC of idelalisib (by 1.8-fold); however, peak plasma concentrations of idelalisib not affected1

Monitor for signs of toxicity; may need to interrupt therapy and reduce dosage if severe adverse effects occur1 (see Dosage Modification for Toxicity under Dosage and Administration)

Midazolam

Increased AUC (by 5.4-fold) and peak plasma concentrations (by 2.4-fold) of midazolam1 14

Avoid concomitant use1

Rifampin

Decreased AUC (by 75%) and peak plasma concentrations (by 58%) of idelalisib1

Avoid concomitant use1

Rosuvastatin

No effect on systemic exposure to rosuvastatin1 14

St. John's wort (Hypericum perforatum)

Possible decreased systemic exposure to idelalisib1

Avoid concomitant use1

Zydelig Pharmacokinetics

Absorption

Bioavailability

Systemic exposure to idelalisib increases in a less than dose-proportional manner over a dosage range of 50–350 mg twice daily in the fasted state.1

Food

Systemic exposure to idelalisib increased by 1.4-fold following administration of a single dose of the drug with a high-fat meal compared with administration in the fasted state.1

Special Populations

In patients with ALT, AST, or bilirubin concentrations above the ULN, systemic exposure to idelalisib increased by 1.7-fold compared with individuals with normal hepatic function.1

In patients with severe renal impairment (Clcr 15–29 mL/minute), systemic exposure to idelalisib was unaffected following administration of a single 150-mg dose of idelalisib.1

Distribution

Extent

Not known whether idelalisib is distributed into human milk.1

Plasma Protein Binding

>84%.1

Elimination

Metabolism

Metabolized by aldehyde oxidase and CYP3A to the inactive metabolite GS-563117.1 Metabolized to a minor extent by UGT1A4.1

Elimination Route

Eliminated in feces (78%) and urine (14%).1 Major inactive metabolite (GS-563117) accounts for 44 or 49% of the dose recovered in feces or urine, respectively.1

Half-life

Mean terminal half-life: 8.2 hours.1

Stability

Storage

Oral

Tablets

20–30°C (may be exposed to 15–30°C).1

Actions

  • Selectively inhibits phosphoinositide 3-kinase isoform delta (PI3Kδ).1 6 7 8 9 10

  • PI3Kδ is highly expressed in hematopoietic cells and mediates B-cell receptor (BCR) signaling critical for B-cell homeostasis and function.2 8 9 12

  • Oversignaling of PI3K, particularly the delta isoform (PI3Kδ), implicated in development of lymphoid malignancies.2 8 13

  • Idelalisib blocks constitutive PI3K/Akt signaling which results in apoptosis.8 11 12

  • Inhibits several other cell signaling pathways, including BCR, CXCR4, and CXCR5, which are involved in the migration of B-cells to lymph nodes and bone marrow.1

  • Induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumor cells.1

  • Inhibits chemotaxis and adhesion, and reduces viability, of lymphoma cells.1

Advice to Patients

  • Importance of instructing patients to read the manufacturer's patient information before starting idelalisib therapy and each time their prescription is refilled.1

  • Importance of advising patients to take idelalisib exactly as prescribed and of not altering the dosage or discontinuing therapy unless advised to do so by their clinician.1 Importance of advising patients to swallow idelalisib tablets whole.1

  • If a dose is missed, importance of advising patients to take it as soon as they remember unless the dose was missed by >6 hours, in which case they should not take the missed dose.1

  • Risk of hepatotoxicity; importance of regular liver function test monitoring.1 Importance of advising patients to immediately report possible symptoms of hepatotoxicity (e.g., abdominal pain [especially right upper quadrant pain], jaundice, dark urine, bruising, bleeding diathesis) to their clinician.1

  • Risk of severe diarrhea or colitis.1 Importance of immediately informing clinician if frequency of bowel movements increases by ≥6 within a day.1

  • Risk of intestinal perforation.1 Importance of immediately informing clinician if new or worsening abdominal pain, chills, fever, nausea, or vomiting occurs.1

  • Risk of pneumonitis.1 Importance of immediately informing clinician if new or worsening respiratory symptoms (e.g., cough, dyspnea, wheezing) occur.1

  • Risk of anaphylaxis or severe dermatologic reactions.1 Importance of immediately informing clinician if anaphylaxis or severe dermatologic reactions occur.1

  • Risk of neutropenia.1 Importance of periodically monitoring CBC during idelalisib therapy.1 Importance of immediately informing clinician if signs of infection (e.g., fever) occur.1

  • Risk of fetal harm.1 Necessity of advising women of childbearing potential to avoid pregnancy and to consider using effective contraceptive methods while receiving idelalisib and for ≥1 month following discontinuance of therapy.1 Importance of women informing clinicians immediately if they become pregnant during therapy or think they may be pregnant.1 If pregnancy occurs, advise pregnant women of potential risk to the fetus.1

  • Importance of advising women to avoid breast-feeding while receiving idelalisib therapy.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., hepatic impairment).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.

Idelalisib

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

100 mg

Zydelig

Gilead Sciences

150 mg

Zydelig

Gilead Sciences

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

Date published: January 01, 2016
Last reviewed: January 01, 2016
Date modified: February 08, 2016

References

1. Gilead Sciences, Inc. Zydelig (idelalisib) tablets prescribing information. Foster City, CA; 2014 Jul.

2. Furman RR, Sharman JP, Coutre SE et al. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014; 370:997-1007. [PubMed 24450857]

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

4. Gopal AK, Kahl BS, de Vos S et al. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014; 370:1008-18. [PubMed 24450858]

5. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number 206545Orig1s000: Medical review(s). From FDA website.

6. Hoellenriegel J, Meadows SA, Sivina M et al. The phosphoinositide 3'-kinase delta inhibitor, CAL-101, inhibits B-cell receptor signaling and chemokine networks in chronic lymphocytic leukemia. Blood. 2011; 118:3603-12. [PubMed 21803855]

7. Fiorcari S, Brown WS, McIntyre BW et al. The PI3-kinase delta inhibitor idelalisib (GS-1101) targets integrin-mediated adhesion of chronic lymphocytic leukemia (CLL) cell to endothelial and marrow stromal cells. PLoS One. 2013; 8:e83830. [PubMed 24376763]

8. Flinn IW, Kahl BS, Leonard JP et al. Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-δ, as therapy for previously treated indolent non-Hodgkin lymphoma. Blood. 2014; 123:3406-13. [PubMed 24615776]

9. Meadows SA, Vega F, Kashishian A et al. PI3Kδ inhibitor, GS-1101 (CAL-101), attenuates pathway signaling, induces apoptosis, and overcomes signals from the microenvironment in cellular models of Hodgkin lymphoma. Blood. 2012; 119:1897-900. [PubMed 22210877]

10. Herman SE, Gordon AL, Wagner AJ et al. Phosphatidylinositol 3-kinase-δ inhibitor CAL-101 shows promising preclinical activity in chronic lymphocytic leukemia by antagonizing intrinsic and extrinsic cellular survival signals. Blood. 2010; 116:2078-88. [PubMed 20522708]

11. Han TT, Fan L, Li JY et al. Role of chemokines and their receptors in chronic lymphocytic leukemia: function in microenvironment and targeted therapy. Cancer Biol Ther. 2014; 15:3-9. [PubMed 24149438]

12. Lannutti BJ, Meadows SA, Herman SE et al. CAL-101, a p110delta selective phosphatidylinositol-3-kinase inhibitor for the treatment of B-cell malignancies, inhibits PI3K signaling and cellular viability. Blood. 2011; 117:591-4. [PubMed 20959606]

13. Castillo JJ, Furman M, Winer ES. CAL-101: a phosphatidylinositol-3-kinase p110-delta inhibitor for the treatment of lymphoid malignancies. Expert Opin Investig Drugs. 2012; 21:15-22. [PubMed 22112004]

14. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number 206545Orig1s000: Clinical Pharmacology and biopharmaceutics review(s). From FDA website.

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