Idelalisib: First global approval

Drugs

Volumn 74, Issue 14, 2014, Pages 1701-1707

  Markham, Anthony ^a  

^a SPRINGER   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BENDAMUSTINE; BORTEZOMIB; CHLORAMBUCIL; EVEROLIMUS; FLUDARABINE; HEMOGLOBIN; IDELALISIB; LENALIDOMIDE; OFATUMUMAB; PHOSPHATIDYLINOSITOL 3 KINASE; PHOSPHATIDYLINOSITOL 3 KINASE P110 DELTA; RITUXIMAB; UNCLASSIFIED DRUG; MOLECULAR LIBRARY; PURINE DERIVATIVE; QUINAZOLINONE DERIVATIVE;

ABDOMINAL PAIN; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTINEOPLASTIC ACTIVITY; APOPTOSIS; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BRONCHITIS; CANCER COMBINATION CHEMOTHERAPY; CANCER INHIBITION; CANCER SURVIVAL; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CHILL; CHRONIC LYMPHATIC LEUKEMIA; COLITIS; DECREASED APPETITE; DIARRHEA; DRUG APPROVAL; DRUG CYTOTOXICITY; DRUG EFFICACY; DRUG ERUPTION; DRUG FECES LEVEL; DRUG FEVER; DRUG INDUCED DISEASE; DRUG INDUSTRY; DRUG OXIDATION; DRUG SELECTIVITY; DRUG URINE LEVEL; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; GASTROESOPHAGEAL REFLUX; GLOMERULUS FILTRATION RATE; HEMOGLOBIN BLOOD LEVEL; HODGKIN DISEASE; HUMAN; HYPERGLYCEMIA; HYPERTRIGLYCERIDEMIA; HYPOGLYCEMIA; HYPONATREMIA; INSOMNIA; INTENTION TO TREAT ANALYSIS; INTESTINE PERFORATION; KIDNEY DISEASE; LIVER TOXICITY; LYMPHOCYTE COUNT; MANTLE CELL LYMPHOMA; MAXIMUM PLASMA CONCENTRATION; METASTASIS INHIBITION; NATURAL KILLER CELL; NEUTROPHIL COUNT; NIGHT SWEAT; NONHODGKIN LYMPHOMA; NOSE OBSTRUCTION; OVERALL SURVIVAL; PAIN; PATIENT; PERIPHERAL EDEMA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEPSIS; SIDE EFFECT; SINUSITIS; STEADY STATE; STOMATITIS; T LYMPHOCYTE; THROMBOCYTE COUNT; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; ADMINISTRATION AND DOSAGE; CHEMISTRY; CONFORMATION; HEMATOLOGIC NEOPLASMS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; LYMPHOMA, B-CELL; MOLECULAR LIBRARY; THERAPEUTIC USE;

DRUG APPROVAL; HEMATOLOGIC NEOPLASMS; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; LYMPHOMA, B-CELL; MOLECULAR CONFORMATION; PURINES; QUINAZOLINONES; SMALL MOLECULE LIBRARIES;

EID: 84910646632     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-014-0285-6     Document Type: Article

References (35)

1. Gopal AK, Kahl BS, Vos S, et al. PI3 K inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370(11):1008-18.
2. Herman SE, Gordon AL, Wagner AJ, et al. Phosphatidylinositol 3-kinase-delta inhibitor CAL-101 shows promising preclinical activity in chronic lymphocytic leukemia by antagonizing intrinsic and extrinsic cellular survival signals. Blood. 2010;116(12):2078-88.
3. U.S. Food and Drug Administration. FDA approves Zydelig for three types of blood cancers [media release]. 2014. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm406387.htm.
4. Gilead Sciences Inc. ZYDELIG (idelalisib) US prescribing Information. 2014. http://www.accessdata.fda.gov/drugsatfda-docs/label/2014/206545lbl.pdf. Accessed 31 Jul 2014.
5. Cameron F, McCormack PL. Obinutuzumab: first global approval. Drugs. 2014;74(1):147-54.
6. Cameron F, Sanford M. Ibrutinib: first global approval. Drugs. 2014;74(2):263-71.
7. Agency EM. Summary of opinion (initial authorisation) Zydelig (idelalisib) [media release]. 24 July 2014. http://www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion-Initial-authorisation/human/003843/WC500170181.pdf.
8. Gilead Sciences Inc. Gilead Sciences to Acquire Calistoga Pharmaceuticals for US375 Million [media release]. 23 February 2011. http://www.gilead.com.
9. Diplomat. Diplomat receives distribution contract for Zydelig(R) (idelalisib) [media release]. 28 Jul 2014. http://www.diplomat.is.
10. Meadows SA, Vega F, Kashishian A, et al. PI3Kdelta 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(8):1897-900.
11. Flinn IW, Kahl BS, Leonard JP, et al. Idelalisib, a selective inhibitor of phosphatidylinositol 3-kinase-delta, as therapy for previously treated indolent non-Hodgkin lymphoma. Blood. 2014;123(22):3406-13.
12. Brown JR, Byrd JC, Coutre SE, et al. Idelalisib, an inhibitor of phosphatidylinositol 3-kinase p110, for relapsed/refractory chronic lymphocytic leukemia. Blood. 2014;123(22):3390-7.
13. Kahl BS, Spurgeon SE, Furman RR, et al. A phase 1 study of the PI3Kd inhibitor idelalisib in patients with relapsed/refractory mantle cell lymphoma (MCL). Blood. 2014;123(22):3398-405.
14. Jin F, Robeson M, Zhou H, et al. Pharmacokinetics and safety of idelalisib, a novel PI3K inhibitor, in Japanese and caucasian subjects [abstract no. 5575]. Blood. 2013;122(21).
15. Jin F, Robeson M, Zhou H, et al. Pharmacokinetics, metabolism and excretion of idelalisib. In: 55th Annual Meeting of the American Society of Hematology, ASH; 10-13 August 2013; New Orleans, LA.
16. Jin F, Robeson M, Zhou H, et al. Evaluation of the effect of idelalisib on the QT/QTC interval in healthy subjects [abstract no. 5573]. Blood. 2013;122(21).
17. Jin F, Robeson M, Zhou H, et al. The pharmacokinetics and safety of idelalisib in subjects with severe renal impairment [abstract no. 5572]. Blood. 2013;122(21).
18. Jin F, Robeson M, Zhou H, et al. The pharmacokinetics and safety of idelalisib in subjects with moderate or severe hepatic impairment. In: 55th Annual Meeting of the American Society of Hematology, ASH; 2013; New Orleans, LA.
19. Jin F, Robeson M, Zhou H, et al. The pharmacokinetics and safety of idelalisib in subjects with moderate or severe hepatic impairment [abstract no. 2592]. J Clin Oncol. (Meeting Abstracts). 2014;32(15 suppl. 1).
20. Jin F, Robeson M, Zhou H, et al. Drug interaction profile of idelalisib and its major metabolite, GS-563117 [abstract no. 2593]. J Clin Oncol. (Meeting Abstracts). 2014;32(15 suppl. 1).
21. Furman RR, Sharman JP, Coutre SE, et al. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014;370(11):997-1007.
22. Furman RR, De Vos S, Leonard JP, et al. A Phase 1 Study Of The Selective PI3Kdelta Inhibitor Idelalisib (GS-1101) In Combination With Therapeutic Anti-CD20 Antibodies (Rituximab or Ofatumumab) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia [abstr. 4180]. In: 55th Annual Meeting and Exposition of the American Society of Hematology; 7-10 December 2013; New Orleans, LA.
23. Barrientos JC, Wagner-Johnston ND, De Vos S, et al. Chemo-immunotherapy combination of idelalisib with bendamustine/rituximab or chlorambucil/rituximab in patients with relapsed/refractory CLL demonstrates efficacy and tolerability. In: 55th Annual Meeting of the American Society of Hematology, ASH; 7-10 December 2013; New Orleans, LA.
24. De Vos S, Furman RR, Barrientos JC, et al. Idelalisib, a Selective Inhibitor Of PI3Kδ, In Combination With Bendamustine, Fludarabine Or Chlorambucil In Patients With Relapsed Or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) [abstr. 2878]. In: 55th Annual Meeting and Exposition of the American Society of Hematology; 7-10 December 2013; New Orleans, LA.
25. Coutre SE, Leonard JP, Barrimentos JC, et al. Clinical Activity Of Idelalisib (GS-1101), a Selective Inhibitor Of PI3Kδ, In Phase 1 and 2 Trials In Chronic Lymphocytic Leukemia (CLL): Effect Of Del(17p)/TP53 Mutation, Del(11q), IGHV Mutation, and NOTCH1 Mutation [abstr. 1632]. In: 55th Annual Meeting and Exposition of the American Society of Hematology; 7-10 December 2014; New Orleans, LA.
26. O'Brien SM, Lamanna N, Kipps TJ, et al. A phase 2 study of the selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor idelalisib (GS-1101) in combination with rituximab in treatment-naive patients 65 years with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Conference Presentation. 2013.
27. O'Brien SM, Lamanna N, Kipps TJ, et al. A phase II study of the selective phosphatidylinositol 3-kinase delta (PI3K) inhibitor idelalisib (GS-1101) in combination with rituximab (R) in treatment-naive patients (pts) 65 years with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). J Clin Oncol (Meeting Abstracts). 2013;31(15 suppl. 1):7005.
28. Wagner-Johnston ND, Gopal AK, Kahl BS, et al. Patient-reported outcomes data from a phase 2 study of idelalisib in patients with refractory indolent B-cell non-Hodgkin lymphoma (iNHL). J Clin Oncol (Meetings Abstracts). 2014;32(15 suppl. 1):e19554.
29. Wagner-Johnston ND, De Vos S, Leonard J, et al. Preliminary results of PI3Kδ inhibitor idelalisib (GS-1101) treatment in combination with everolimus, bortezomib, or bendamustine/rituximab in patients with previously treated mantle cell lymphoma (MCL). Conference Presentation. 2013.
30. Younes A, Moskowitz A, Moskowitz C, et al. PILOT phase 2 study of idelalisib, a selective inhibitor of PI3Kδ, in patients with heavily pretreated hodgkin lymphoma (HL). Conference presentation. 2013.
31. Flinn I, Kimby E, Cotter FE, et al. A phase III, randomized, controlled study evaluating the efficacy and safety of idelalisib (GS-1101) in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [abstract no. TPS7131]. J Clin Oncol. 2013;31(suppl.).
32. Eradat HA, Robak T, Delgado J, et al. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of idelalisib (GS-1101) in combination with bendamustine and rituximab for previously treated chronic lymphocytic leukemia (CLL) [abstract no. TPS7127]. J Clin Oncol. 2014;32(5 suppl.).
33. Salles GA, Lamanna N, Amin BR, et al. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated chronic lymphocytic leukemia [abstract no. TPS7123]. J Clin Oncol. 2014;32(5 suppl.).
34. Salles GA, Ervin TJ, Dichmann R, et al. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated indolent non-Hodgkin lymphomas (iNHL) [abstract no. TPS8620]. J Clin Oncol. 2014;32(5 suppl.).
35. de Vos S, Sehn LH, Mulligan SP, et al. A phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of idelalisib (GS-1101) in combination with bendamustine and rituximab for previously treated indolent non-Hodgkin lymphomas (iNHL) [abstract no. TPS8618]. J Clin Oncol. 2013;31(suppl.).