Difference between revisions of "Idelalisib (Zydelig)"
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==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Chronic lymphocytic leukemia]] | *[[Chronic lymphocytic leukemia]] | ||
| − | |||
*[[Marginal zone lymphoma]] | *[[Marginal zone lymphoma]] | ||
*[[Waldenström macroglobulinemia]] | *[[Waldenström macroglobulinemia]] | ||
| + | |||
| + | ==Diseases for which it was used== | ||
| + | *[[Follicular lymphoma]] | ||
==Patient drug information== | ==Patient drug information== | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | ===[[Chronic lymphocytic leukemia]]=== | + | ===[[Chronic lymphocytic leukemia]] - '''PARTIALLY WITHDRAWN'''=== |
*7/23/2014: [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)'' | *7/23/2014: [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)'' | ||
*7/23/2014: [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)'' | *7/23/2014: [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)'' | ||
| − | ===[[Follicular lymphoma]]=== | + | **1/14/2022: Indication voluntarily withdrawn by the manufacturer. |
| + | ===[[Follicular lymphoma]] - '''WITHDRAWN'''=== | ||
*7/23/2014: [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)'' | *7/23/2014: [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)'' | ||
| + | **1/14/2022: Indication voluntarily withdrawn by the manufacturer. | ||
==Also known as== | ==Also known as== | ||
Revision as of 00:19, 23 February 2022
On 3/21/2016 Gilead announced that they were stopping seven clinical trials in patients with CLL, SLL, and iNHL due to excess deaths and increased rates of SAEs. A REMS program has also been announced.
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
Follow this link for information on the Zydelig REMS Program.
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 used
Diseases for which it was used
Patient drug information
- Patient counseling information may be found in the Idelalisib (Zydelig) package insert[1]
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
- 7/23/2014: 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)
- 7/23/2014: 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)
- 1/14/2022: Indication voluntarily withdrawn by the manufacturer.
Follicular lymphoma - WITHDRAWN
- 7/23/2014: Accelerated approval for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies. (Based on DELTA)
- 1/14/2022: Indication voluntarily withdrawn by the manufacturer.
Also known as
- Code names: CAL-101, GS 1101, GS-1101
- Brand name: Zydelig
References
- ↑ 1.0 1.1 1.2 Idelalisib (Zydelig) package insert
- ↑ Idelalisib (Zydelig) package insert (locally hosted backup)
- ↑ Zydelig manufacturer's website
- ↑ 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.
- ↑ 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.
- ↑ 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