News Feature | January 16, 2014

FDA Approves Application Review For Refractory Indolent Non-Hodgkin's Lymphoma

Source: BioProcess Online

By Cassandra Leger

The FDA has made an application approval for a drug to treat Refractory Indolent Non-Hodgkin's Lymphoma. The announcement was made by Gilead Sciences on January 13, 2014. The FDA will be reviewing Gilead Sciences’ Idelalisib drug, an oral inhibitor of phosphoinositide 3-kinase (PI3K delta) designed to be used as a treatment for Indolent Non-Hodgkin's Lymphoma (iNHL). According to the documentation, the FDA has issued a review date for September 11, 2014 under the Prescription Drug User Fee Act.

Indolent Non-Hodgkin’s Lymphoma presents challenges in the pharmaceutical industry because the majority of diagnoses occur at advanced stages. Because of this, the disease has already become progressively worse and harder to treat at the time of diagnosis. This disease poses a median life span for people suffering of 8-10 years from the time they are diagnosed.

The New Drug Application that was submitted by Gilead Sciences on September 11, 2013was supported by a phase 2 study in which a team evaluated patients suffering from iNHL and being treated with Idelalisib. These were patients who were nonresponsive to Rituximab and alkylating-agent-containing chemotherapy.

Shortly after Gilead Sciences submitted their NDA, the FDA awarded the company their breakthrough therapy designation, but it was for relapsed Chronic Lymphocytic Leukemia. Gilead Sciences also submitted a NDA for Idelalisib for use in the treatment of Chronic Lymphocytic Leukemia in December 2013.

Currently Idelalisib is being developed by Gilead Sciences’ clinical development program as a singleton treatment as well as an agent of combination therapy. Idelalisib’s study roster for iNHL includes Study 101-09, which was the supporter if it’s NDA and two Phase 3 studies of previously treated patients. Idelalisib’s study roster for Chronic Lymphocytic Leukemia includes three Phase 3 studies conducted on previously treated patients and a combination therapy of the drug in conjunction with GS-9973.