Difference between revisions of "Idelalisib (Zydelig)"

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==General information==
 
==General information==
−
Class/mechanism: Isoform-selective PI3K (phosphatidylinositol 3-kinase) inhibitor. Idelalisib inhibits class I isoform p110 delta (p110δ), which is one of the mediators of activation of the PI3K pathway and is expressed at high levels by hematopoietic cells, particularly leukocytes. Disruption of the various pathways regulated by PI3K is hypothesized to have therapeutic applications by affecting cellular metabolism, growth, oncogenesis, and survival.<ref name=insert>[http://www.gilead.com/~/media/Files/pdfs/medicines/oncology/zydelig/zydelig_pi.pdf Idelalisib (Zydelig) package insert]</ref><ref><ref>[[Media:Idelalisib.pdf | Idelalisib (Zydelig) package insert (locally hosted backup)]]</ref><ref>[http://zydelig.com/ Zydelig manufacturer's website]</ref><ref>S. E. Coutre, J. C. Byrd, R. R. Furman, J. R. Brown, D. M. Benson, N. D. Wagner-Johnston, I. W. Flinn, B. S. Kahl, S. E. F. Spurgeon, B. J. Lannutti, H. K. W. Hsu, R. Ulrich, S. Peterman, L. Holes, L. L. Miller, A. S. Yu. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=83782 Phase I study of CAL-101, an isoform-selective inhibitor of phosphatidylinositol 3-kinase P110d, in patients with previously treated chronic lymphocytic leukemia.] 2011 ASCO Annual Meeting abstract 6631.</ref><ref>I. W. Flinn, J. C. Byrd, R. R. Furman, J. R. Brown, T. S. Lin, C. Bello, N. A. Giese, A. S. Yu. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=34213 Preliminary evidence of clinical activity in a phase I study of CAL-101, a selective inhibitor of the p1108 isoform of phosphatidylinositol 3-kinase (P13K), in patients with select hematologic malignancies.] 2009 ASCO Annual Meeting abstract 3543.</ref><ref>Lannutti BJ, Meadows SA, Herman SE, Kashishian A, Steiner B, Johnson AJ, Byrd JC, Tyner JW, Loriaux MM, Deininger M, Druker BJ, Puri KD, Ulrich RG, Giese NA. [http://bloodjournal.hematologylibrary.org/content/117/2/591.full CAL-101, a p110delta selective phosphatidylinositol-3-kinase inhibitor for the treatment of B-cell malignancies, inhibits PI3K signaling and cellular viability.] Blood. 2011 Jan 13;117(2):591-4. Epub 2010 Oct 19. [http://www.ncbi.nlm.nih.gov/pubmed/20959606 PubMed]</ref>
+
Class/mechanism: Isoform-selective PI3K (phosphatidylinositol 3-kinase) inhibitor. Idelalisib inhibits class I isoform p110 delta (p110δ), which is one of the mediators of activation of the PI3K pathway and is expressed at high levels by hematopoietic cells, particularly leukocytes. Inhibition of the PI3Kδ kinase pathway affects B-cell receptor (BCR), CXCR4, and CXCR5 signaling, disrupting trafficking and homing of B-cells to the lymph nodes and bone marrow. Lymphoma cells treated with idelalisib have been observed to have impaired chemotaxis, adhesion properties, and cell viability.<ref name=insert>[http://www.gilead.com/~/media/Files/pdfs/medicines/oncology/zydelig/zydelig_pi.pdf Idelalisib (Zydelig) package insert]</ref><ref>[[:File:Idelalisib.pdf | Idelalisib (Zydelig) package insert (locally hosted backup)]]</ref><ref>[http://zydelig.com/ Zydelig manufacturer's website]</ref><ref>S. E. Coutre, J. C. Byrd, R. R. Furman, J. R. Brown, D. M. Benson, N. D. Wagner-Johnston, I. W. Flinn, B. S. Kahl, S. E. F. Spurgeon, B. J. Lannutti, H. K. W. Hsu, R. Ulrich, S. Peterman, L. Holes, L. L. Miller, A. S. Yu. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=83782 Phase I study of CAL-101, an isoform-selective inhibitor of phosphatidylinositol 3-kinase P110d, in patients with previously treated chronic lymphocytic leukemia.] 2011 ASCO Annual Meeting abstract 6631.</ref><ref>I. W. Flinn, J. C. Byrd, R. R. Furman, J. R. Brown, T. S. Lin, C. Bello, N. A. Giese, A. S. Yu. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=34213 Preliminary evidence of clinical activity in a phase I study of CAL-101, a selective inhibitor of the p1108 isoform of phosphatidylinositol 3-kinase (P13K), in patients with select hematologic malignancies.] 2009 ASCO Annual Meeting abstract 3543.</ref><ref>Lannutti BJ, Meadows SA, Herman SE, Kashishian A, Steiner B, Johnson AJ, Byrd JC, Tyner JW, Loriaux MM, Deininger M, Druker BJ, Puri KD, Ulrich RG, Giese NA. [http://www.bloodjournal.org/content/117/2/591.full CAL-101, a p110delta selective phosphatidylinositol-3-kinase inhibitor for the treatment of B-cell malignancies, inhibits PI3K signaling and cellular viability.] Blood. 2011 Jan 13;117(2):591-4. Epub 2010 Oct 19. [https://pubmed.ncbi.nlm.nih.gov/20959606/ PubMed]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
  
−
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
+
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
 +
 
 +
==Diseases for which it is established ''(work in progress)''==
 +
*[[Chronic lymphocytic leukemia]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
−
*[[Chronic lymphocytic leukemia (CLL) and Small lymphocytic lymphoma (SLL)]]
+
*[[Marginal zone lymphoma]]
−
==Idelalisib (CAL-101)==
+
*[[Waldenström macroglobulinemia]]
  
−
===Regimen, Gopal et al. 2014 (DELTA)===
+
==Diseases for which it was used==
−
<span
+
*[[Follicular lymphoma]]
−
style="background:#EEEE00;
 
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase II</span>
 
  
−
*[[Idelalisib (CAL-101)]] 150 mg PO BID
+
==Patient drug information==
 +
*Patient counseling information may be found in the [http://www.gilead.com/~/media/Files/pdfs/medicines/oncology/zydelig/zydelig_pi.pdf Idelalisib (Zydelig) package insert]<ref name="insert"></ref>
  
−
'''Continued until progression, death, or unacceptable toxicity'''
+
==Suggestions for SAE monitoring/prevention==
 +
*Administer [[:Category:PCP_prophylaxis|PCP/PJP prophylaxis]] throughout treatment
 +
*Monitor for CMV infection (positive PCR or antigen test) and discontinue treatment if any evidence of infection
 +
*Monitor blood counts at least every 2 weeks for the first 6 months of treatment
 +
**Increase monitoring to at least weekly if ANC < 1000/mm<sup>3</sup>
  
−
===References===
+
==History of changes in FDA indication==
−
# Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma. N Engl J Med. 2014 Jan 22. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1314583 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/24450858 PubMed]
+
===[[Chronic lymphocytic leukemia]] - '''PARTIALLY WITHDRAWN'''===
−
# Brown JR, Byrd JC, Coutre SE, Benson DM, Flinn IW, Wagner-Johnston ND,Spurgeon SE, Kahl BS, Bello C, Webb HK, Johnson DM, Peterman S, Li D, Jahn TM, Lannutti BJ, Ulrich RG, Yu AS, Miller LL, Furman RR. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110δ, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014 May 29;123(22):3390-7. Epub 2014 Mar 10. [http://bloodjournal.hematologylibrary.org/content/123/22/3390 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/24615777 PubMed]
+
*2014-07-23: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm406387.htm FDA approved] for the treatment of patients with relapsed [[Chronic lymphocytic leukemia | chronic lymphocytic leukemia (CLL)]], in combination with [[Rituximab (Rituxan) | rituximab]], in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. ''(Based on GS-US-312-0116)''
 +
*2014-07-23: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm406387.htm Accelerated approval] for the treatment of patients with relapsed [[Chronic lymphocytic leukemia | small lymphocytic lymphoma (SLL)]] in patients who have received at least two prior systemic therapies. ''(Based on DELTA)''
 +
**2022-01-14: Accelerated approval for the treatment of patients with relapsed [[Chronic lymphocytic leukemia | small lymphocytic lymphoma (SLL)]] in patients who have received at least two prior systemic therapies voluntarily withdrawn by the manufacturer. ''(No supporting studies are cited)''
 +
===[[Follicular lymphoma]] - '''WITHDRAWN'''===
 +
*2014-07-23: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm406387.htm Accelerated approval] for the treatment of patients with relapsed [[Follicular lymphoma | follicular B-cell non-Hodgkin lymphoma (FL)]] in patients who have received at least two prior systemic therapies. ''(Based on DELTA)''
 +
**2022-01-14: Accelerated approval for the treatment of patients with relapsed [[Follicular lymphoma | follicular B-cell non-Hodgkin lymphoma (FL)]] in patients who have received at least two prior systemic therapies voluntarily withdrawn by the manufacturer. ''(No supporting studies are cited)''
  
−
==Idelalisib & Rituximab==
+
==History of changes in EMA indication==
 +
*2014-09-18: Initial authorization
 +
*Zydelig is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
 +
*Zydelig is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.
 +
*Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
 +
==History of changes in Health Canada indication==
 +
*2015-03-27: Initial notice of compliance with conditions
 +
*2020-04-21: Conditions were met
 +
==Also known as==
 +
*'''Code names:''' CAL-101, GS-1101
 +
*'''Brand name:''' Zydelig
  
−
===Regimen, Furman et al. 2014===
+
==References==
−
<span
+
<references/>
−
style="background:#00CD00;
 
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase III</span>
 
−
 
 
−
*[[Idelalisib (CAL-101)]] 150 mg PO BID
 
−
*[[Rituximab (Rituxan)]] 375 mg/m2 IV once on first dose, then 500 mg/m2 IV once on subsequent doses
 
−
 
 
−
'''Rituximab is given every two weeks x 5 doses then every three weeks x 3 doses for 8 doses, total.'''
 
−
 
 
−
'''Idelalisib continues until progression, and can be increased to 300 mg PO BID at that point.'''
 
−
 
 
−
===References===
 
−
# Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2014 Jan 22. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1315226 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/24450857 PubMed]
 
−
 
 
−
==[[Follicular lymphoma]]==
 
−
 
 
−
==Idelalisib (CAL-101)==
 
−
 
 
−
===Regimen, Gopal et al. 2014 (DELTA)===
 
−
<span
 
−
style="background:#EEEE00;
 
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase II</span>
 
−
 
 
−
*[[Idelalisib (CAL-101)]] 150 mg PO BID
 
−
 
 
−
'''Continued until progression, death, or unacceptable toxicity'''
 
−
 
 
−
===References===
 
−
# Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma. N Engl J Med. 2014 Jan 22. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1314583 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/24450858 PubMed]
 
−
 
 
−
==[[Mantle cell lymphoma]]==
 
−
 
 
−
==[[Marginal zone lymphoma]]==
 
  
−
==Idelalisib (CAL-101)==
+
[[Category:Drugs]]
 +
[[Category:Oral medications]]
  
−
===Regimen, Gopal et al. 2014 (DELTA)===
 
−
<span
 
−
style="background:#EEEE00;
 
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase II</span>
 
  
−
*[[Idelalisib (CAL-101)]] 150 mg PO BID
+
[[Category:PI3K delta inhibitors]]
  
−
'''Continued until progression, death, or unacceptable toxicity'''
+
[[Category:Chronic lymphocytic leukemia medications]]
 +
[[Category:Marginal zone lymphoma medications]]
 +
[[Category:Waldenström macroglobulinemia medications]]
  
−
===References===
+
[[Category:Follicular lymphoma medications (historic)]]
−
# Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma. N Engl J Med. 2014 Jan 22. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1314583 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/24450858 PubMed]
 
−
 
 
−
==[[Waldenström macroglobulinemia]]==
 
−
 
 
−
==Idelalisib (CAL-101)==
 
−
 
 
−
===Regimen, Gopal et al. 2014 (DELTA)===
 
−
<span
 
−
style="background:#EEEE00;
 
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase II</span>
 
−
 
 
−
*[[Idelalisib (CAL-101)]] 150 mg PO BID
 
−
 
 
−
'''Continued until progression, death, or unacceptable toxicity'''
 
−
 
 
−
===References===
 
−
# Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma. N Engl J Med. 2014 Jan 22. [Epub ahead of print] [http://www.nejm.org/doi/full/10.1056/NEJMoa1314583 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/24450858 PubMed]
 
−
 
 
−
==Clinical trials==
 
−
*[http://clinicaltrials.gov/ct2/show/NCT01282424 Efficacy and Safety Study of CAL-101 in Patients With Indolent B-Cell Non-Hodgkin Lymphoma (DELTA) (101-09)]
 
−
*[http://clinicaltrials.gov/ct2/show/NCT01203930 A Study of CAL-101 and Rituximab in Elderly Patients With Untreated CLL or SLL (101-08)]
 
−
*[http://clinicaltrials.gov/ct2/show/NCT01088048 Study to Investigate CAL-101 in Combination With Chemotherapeutic Agents and CD20 mAb in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia]
 
−
*[http://clinicaltrials.gov/ct2/show/NCT01090414 An Extension Study for Patients Who Are Deriving Benefit With CAL-101 to Continue on Treatment at the End of the Current Study (101-99)]
 
−
*[http://clinicaltrials.gov/ct2/show/NCT01306643 Safety and Efficacy Study of CAL-101 in Patients With Previously Treated Low-grade Lymphoma]
 
−
 
 
−
==Patient drug information==
 
−
No information available.
 
−
 
 
−
==History of changes in FDA indication==
 
−
*7/23/2014: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm406387.htm FDA approved] "for the treatment of patients with:
 
−
**Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
 
−
**Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies.
 
−
**Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies."
 
−
 
 
−
==Also known as==
 
−
CAL-101, 5-fluoro-3-phenyl-2-[(S)-1-(9H-purin-6-ylamino)-propyl]-3H-quinazolin-4-one, GS 1101, GS-1101.
 
−
 
 
−
==References==
 
−
<references/>
 
  
−
[[Category:Kinase inhibitors]]
+
[[Category:EMA approved in 2014]]
−
[[Category:PIK3CA inhibitors]]
+
[[Category:FDA approved in 2014]]
−
[[Category:Drugs FDA approved in 2014]]
+
[[Category:Health Canada approved in 2015]]

Latest revision as of 11:23, 9 April 2024

General information

Class/mechanism: Isoform-selective PI3K (phosphatidylinositol 3-kinase) inhibitor. Idelalisib inhibits class I isoform p110 delta (p110δ), which is one of the mediators of activation of the PI3K pathway and is expressed at high levels by hematopoietic cells, particularly leukocytes. Inhibition of the PI3Kδ kinase pathway affects B-cell receptor (BCR), CXCR4, and CXCR5 signaling, disrupting trafficking and homing of B-cells to the lymph nodes and bone marrow. Lymphoma cells treated with idelalisib have been observed to have impaired chemotaxis, adhesion properties, and cell viability.[1][2][3][4][5][6]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is established (work in progress)

Diseases for which it is used

Diseases for which it was used

Patient drug information

Suggestions for SAE monitoring/prevention

  • Administer PCP/PJP prophylaxis throughout treatment
  • Monitor for CMV infection (positive PCR or antigen test) and discontinue treatment if any evidence of infection
  • Monitor blood counts at least every 2 weeks for the first 6 months of treatment
    • Increase monitoring to at least weekly if ANC < 1000/mm3

History of changes in FDA indication

Chronic lymphocytic leukemia - PARTIALLY WITHDRAWN

  • 2014-07-23: FDA approved for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. (Based on GS-US-312-0116)
  • 2014-07-23: Accelerated approval for the treatment of patients with relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies. (Based on DELTA)
    • 2022-01-14: Accelerated approval for the treatment of patients with relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies voluntarily withdrawn by the manufacturer. (No supporting studies are cited)

Follicular lymphoma - WITHDRAWN

History of changes in EMA indication

  • 2014-09-18: Initial authorization
  • Zydelig is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
  • Zydelig is indicated in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.
  • Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.

History of changes in Health Canada indication

  • 2015-03-27: Initial notice of compliance with conditions
  • 2020-04-21: Conditions were met

Also known as

  • Code names: CAL-101, GS-1101
  • Brand name: Zydelig

References

  1. ↑ 1.0 1.1 1.2 Idelalisib (Zydelig) package insert
  2. ↑ Idelalisib (Zydelig) package insert (locally hosted backup)
  3. ↑ Zydelig manufacturer's website
  4. ↑ S. E. Coutre, J. C. Byrd, R. R. Furman, J. R. Brown, D. M. Benson, N. D. Wagner-Johnston, I. W. Flinn, B. S. Kahl, S. E. F. Spurgeon, B. J. Lannutti, H. K. W. Hsu, R. Ulrich, S. Peterman, L. Holes, L. L. Miller, A. S. Yu. Phase I study of CAL-101, an isoform-selective inhibitor of phosphatidylinositol 3-kinase P110d, in patients with previously treated chronic lymphocytic leukemia. 2011 ASCO Annual Meeting abstract 6631.
  5. ↑ I. W. Flinn, J. C. Byrd, R. R. Furman, J. R. Brown, T. S. Lin, C. Bello, N. A. Giese, A. S. Yu. Preliminary evidence of clinical activity in a phase I study of CAL-101, a selective inhibitor of the p1108 isoform of phosphatidylinositol 3-kinase (P13K), in patients with select hematologic malignancies. 2009 ASCO Annual Meeting abstract 3543.
  6. ↑ Lannutti BJ, Meadows SA, Herman SE, Kashishian A, Steiner B, Johnson AJ, Byrd JC, Tyner JW, Loriaux MM, Deininger M, Druker BJ, Puri KD, Ulrich RG, Giese NA. CAL-101, a p110delta selective phosphatidylinositol-3-kinase inhibitor for the treatment of B-cell malignancies, inhibits PI3K signaling and cellular viability. Blood. 2011 Jan 13;117(2):591-4. Epub 2010 Oct 19. PubMed
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