NDA Submitted for Idelalisib for Indolent Non-Hodgkin Lymphoma

Share this content:

Gilead Sciences announced that a New Drug Application (NDA) has been submitted to the FDA for idelalisib, an investigational, targeted, oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, for the treatment of indolent non-Hodgkin lymphoma (iNHL). 

Gilead's NDA submission for idelalisib is supported by data from a single-arm, open-label Phase 2 efficacy and safety study (Study 101-09) of 125 patients with iNHL refractory to rituximab and to alkylating-agent-containing-chemotherapy. All patients received idelalisib 150mg twice daily and were allowed to continue daily dosing as long as they benefited from therapy. The primary endpoint of the study was overall response rate, defined as the proportion of patients achieving a confirmed complete or partial response with idelalisib treatment. 

Related: Hematologic Cancers Resource Center

Idelalisib achieved an overall response rate of 53.6% with a median duration of response of 11.9 months. Median progression-free survival for all patients was 11.4 months. Eighty nine percent of patients experienced lymph node shrinkage.

Gilead's clinical development program for idelalisib includes two Phase 3 studies of idelalisib in combination with approved therapies for previously treated iNHL patients and three Phase 3 studies evaluating idelalisib in combination with approved therapies for patients with previously treated chronic lymphocytic leukemia (CLL).

For more information call (800) 445-3235 or visit Gilead.com.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs