September 11, 2013
Gilead Submits New Drug Application to U.S. FDA for Idelalisib for the Treatment of Indolent Non-Hodgkin’s Lymphoma
-- Idelalisib Would Be First PI3K Delta Targeted Therapy Approved for a Hematological Cancer and First New Class of Therapy Approved for iNHL in More Than a Decade --
Indolent non-Hodgkin’s lymphoma refers to a group of largely incurable slow-growing lymphomas that run a relapsing course after therapy and lead ultimately to life-threatening complications such as serious infections and marrow failure. Most iNHL patients are diagnosed at an advanced stage of disease, and median survival from time of initial diagnosis for patients with the most common form of iNHL, follicular lymphoma, is 8 to 10 years. The outlook for refractory iNHL patients is significantly poorer.
“Gilead is committed to advancing a pipeline of novel cancer therapies
that have the potential to improve the lives of patients,” said John C.
Martin, PhD, Chairman and Chief Executive Officer of
Gilead’s NDA for idelalisib is supported by data from a single-arm,
open-label Phase 2 study (Study 101-09) of 125 patients with iNHL
refractory to rituximab and to alkylating-agent-containing chemotherapy.
In an interim data analysis presented in June at the
Updated results from this study were included in the NDA filing and have
also been submitted for presentation at an upcoming scientific
conference. Gilead plans to file for regulatory approval of idelalisib
Idelalisib is an investigational, targeted, highly selective oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that is critical for the activation, proliferation and survival of B lymphocytes. PI3K delta signaling is hyperactive in many B-cell leukemias and lymphomas and drives proliferation, survival and trafficking to lymphoid tissue. Idelalisib is being developed both as a single agent and in combination with approved and investigational therapies.
In addition to the Phase 2 iNHL study, Gilead’s clinical development program for idelalisib includes two Phase 3 studies of idelalisib in combination with approved therapies for patients with previously treated iNHL and three Phase 3 studies evaluating the drug in combination with approved therapies for patients with previously treated chronic lymphocytic leukemia (CLL). Combination therapy with idelalisib and GS-9973, Gilead’s novel spleen tyrosine kinase (Syk) inhibitor, also is being evaluated in a Phase 2 trial of patients with relapsed or refractory CLL, iNHL and other lymphoid and hematological malignancies.
Additional information about clinical studies of idelalisib and Gilead’s other investigational cancer agents can be found at www.clinicaltrials.gov. Idelalisib and GS-9973 are investigational products and their safety and efficacy have not yet been established.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that Gilead will be unable to file for regulatory approval in the
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Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Nathan Kaiser, 650-522-1853