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|U.S. Food and Drug Administration Approves Gilead’s Zydelig® (idelalisib) for Relapsed Chronic Lymphocytic Leukemia, Follicular Lymphoma and Small Lymphocytic Lymphoma|
-- 82 Percent Reduction in Risk of Disease Progression or Death When Combined with Rituximab Compared to Rituximab Alone in Patients with Relapsed Chronic Lymphocytic Leukemia --
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“Zydelig is a much needed new treatment option for appropriate patients
with CLL and these indolent lymphomas who have experienced relapses and
have limited, if any, treatment options,” said Bruce Cheson, MD,
Professor of Medicine, Head of Hematology and Director of
Over 200,000 Americans are living with CLL, FL or SLL, slow-growing incurable blood cancers that can lead to life-threatening complications such as anemia, serious infection and bone marrow failure requiring treatment. Relapse commonly occurs after initial chemoimmunotherapy and many patients with relapsed CLL, FL or SLL are unable to tolerate chemotherapy, which may limit their treatment options.
“Gilead is committed to the development of novel cancer therapies and we
are proud to have this opportunity to make a difference in the lives of
people living with these cancers,” said
The product’s approval in CLL is supported primarily by data from a
randomized, placebo-controlled Phase 3 trial (Study 116) of Zydelig plus
rituximab in 220 patients with relapsed CLL who were not able to
tolerate standard chemotherapy. Study 116 was stopped early in
Zydelig’s accelerated approval in FL and SLL, two types of indolent
non-Hodgkin lymphoma, is supported by data from a single-arm Phase 2
study (Study 101-09) of Zydelig monotherapy in patients refractory to
rituximab and alkylating-agent-containing chemotherapy (FL: n=72; SLL:
n=26). In the study, Zydelig achieved an overall response rate of 54
percent (range: 42-66 percent) and 58 percent (range: 37-77 percent),
respectively, in FL and SLL patients. Of the responses seen in FL
patients, 8 percent (n=6) were complete responses; all 15 responses in
SLL patients were partial responses. The median duration of response was
11.9 months in SLL patients (range: 0.0, 14.7 months) and median
duration of response was not reached in FL patients (range: 0.0, 14.8
months). Improvement in patient survival or disease related symptoms has
not been established in these indications. Results of Study 116 and
Study 101-09 were published in The
Zydelig has a BOXED WARNING in its product label regarding the risks of fatal and serious toxicities: hepatic, severe diarrhea, colitis, pneumonitis and intestinal perforation; see below for Important Safety Information, including contraindications and warnings and precautions.
The most common adverse reactions (incidence ≥20 percent; all grades) in patients given Zydelig with or without rituximab are diarrhea, pyrexia, fatigue, nausea, cough, abdominal pain, chills and rash. The most common lab abnormalities (incidence ≥30 percent; all grades) in clinical studies were neutropenia, hypertriglyceridemia, hyperglycemia and ALT/AST elevations (indicators of liver function).
U.S. Patient Support Program
Gilead is committed to ensuring that patients with CLL, FL and SLL can access Zydelig and has launched Zydelig AccessConnect™ to provide assistance to appropriate patients who are uninsured, underinsured or who need financial assistance to pay for the medicine. The program consists of an integrated offering of support services for patients and providers, including:
Information about how to apply for any of these forms of assistance, and more information on authorized distributors and specialty pharmacies can be found at www.zydeligaccessconnect.com or by calling 1-844-6ACCESS (1-844-622-2377) between 8 a.m. and 8 p.m. ET.
About Zydelig (idelalisib)
Zydelig is an oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that plays a role in the activation, proliferation and viability of B cells, a critical component of the immune system. PI3K delta signaling is active in many B-cell leukemias and lymphomas, and by inhibiting the protein, Zydelig blocks several cellular signaling pathways that drive B-cell viability. Zydelig is indicated in combination with rituximab for the treatment of relapsed chronic lymphocytic leukemia in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities and as monotherapy for relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior therapies. The FL and SLL indications were granted accelerated approval based on overall response rate; improvement in patient survival or disease related symptoms has not been established in these indications. Continued approval for these indications is contingent upon verification of clinical benefit in confirmatory trials. Zydelig is available as 150 mg and 100 mg tablets, administered orally twice-daily; 150 mg is the recommended starting dose (see Important Safety Information below for dose modification instructions).
Important Safety Information
BOXED WARNING: FATAL and SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS and INTESTINAL PERFORATION
Warnings and Precautions
Dosage and Administration
About Gilead Sciences
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 physicians and patients may not see advantages of Zydelig over other therapies and may therefore be reluctant to prescribe the product. In addition, European and other regulatory agencies may not approve Zydelig in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use. Further, additional studies of Zydelig may produce unfavorable results. 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 March 31, 2014, 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.
Zydelig and AccessConnect are registered trademarks and trademarks of
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.
Gilead Sciences, Inc.
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