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Zydelig (Idelalisib) - Summary

 
 



WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, and INTESTINAL PERFORATION

  • Fatal and/or serious hepatotoxicity occurred in 14% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig as recommended [see Dosage and Administration, Warnings and Precautions].
  • Fatal and/or serious and severe diarrhea or colitis occurred in 14% of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig as recommended [see Dosage and Administration, Warnings and Precautions].
  • Fatal and serious pneumonitis can occur in Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig as recommended [see Dosage and Administration, Warnings and Precautions].
  • Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig for intestinal perforation [see Warnings and Precautions].
 

ZYDELIG SUMMARY

Idelalisib is an inhibitor of phosphatidylinositol 3-kinase, PI3Kδ.

Relapsed Chronic Lymphocytic Leukemia

Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.

Relapsed Follicular B-cell non-Hodgkin Lymphoma

Zydelig is indicated for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies.

Accelerated approval was granted for this indication based on Overall Response Rate [see Clinical Studies]. An improvement in patient survival or disease related symptoms has not been established. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Relapsed Small Lymphocytic Lymphoma

Zydelig is indicated for the treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies.

Accelerated approval was granted for this indication based on Overall Response Rate [see Clinical Studies]. An improvement in patient survival or disease related symptoms has not been established. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.


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NEWS HIGHLIGHTS

Published Studies Related to Zydelig (Idelalisib)

Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. [2014]
are needed for this patient population... CONCLUSIONS: The combination of idelalisib and rituximab, as compared with

more studies >>

Clinical Trials Related to Zydelig (Idelalisib)

Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia [Completed]
This study will evaluate the safety and clinical activity of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, an mTOR inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).

A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Active, not recruiting]
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will be randomized with a 1: 1 ratio into 1 of the 2 treatment arms to receive either idelalisib or placebo. All subjects will be administered bendamustine and rituximab.

Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma [Recruiting]
This study will evaluate the safety, pharmacodynamics, pharmacokinetics (PK), and efficacy of single agent idelalisib and in combination with chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma. This study will also define the the maximum tolerated dose (MTD) of idelalisib in combination with chemotherapy.

Efficacy and Safety Study of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma [Active, not recruiting]
The purpose of this study is to evaluate the efficacy and safety of idelalisib in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to assess the overall response rate. Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant patients as long as the study is still ongoing and the patients appear to be benefiting from treatment with acceptable safety.

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Completed]
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1: 1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

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Page last updated: 2014-11-30

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