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-- 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 --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 11, 2013--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company
has submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for approval of idelalisib, an investigational,
targeted, oral inhibitor of PI3K delta, for the treatment of indolent
non-Hodgkin’s lymphoma (iNHL). The data submitted in this NDA support
the use of idelalisib for patients with iNHL that is refractory
(non-responsive) to rituximab and to alkylating-agent-containing
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
“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 Sciences.
“Based on the rate and duration of response observed to date in this
highly refractory iNHL patient population, we believe idelalisib could
become an important new therapy for patients who have limited treatment
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 International
Conference on Malignant Lymphoma in Lugano, Switzerland, single-agent
idelalisib achieved an overall response rate of 53.6 percent, with a
median duration of response of 11.9 months. Median progression-free
survival for all patients was 11.4 months. 89 percent of patients
experienced lymph node shrinkage. The most common Grade ≥3 adverse
events or laboratory abnormalities were diarrhea (10 percent),
transaminase elevations (measure of liver function, 13 percent) and
neutropenia (26 percent).
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
in the European Union in the fourth quarter of this year.
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
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,
California, Gilead has operations in North America, Europe and Asia
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
European Union in the anticipated timeline. In addition, the FDA and
other regulatory agencies may not approve idelalisib, and any marketing
approvals, if granted, may have significant limitations on their use.
Additionally, clinical trials involving idelalisib, including in
combination with GS-9973 or other product candidates, may produce
unfavorable results. As a result, idelalisib may never be successfully
commercialized. Further, Gilead may make a strategic decision to
discontinue development of idelalisib if, for example, Gilead believes
commercialization will be difficult relative to other opportunities in
its pipeline. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2013, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936InvestorsorNathan