July 25, 2014
European CHMP Adopts Positive Opinion for Gilead’s Zydelig® (idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma
CLL and FL are 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 chemo-immunotherapy and many patients with relapsed CLL or FL are unable to tolerate chemotherapy, which may limit their treatment options.
The CHMP positive opinion for Zydelig is based on data from two clinical
trials – Study 116 and Study 101-09. Study 116, a pivotal Phase 3 trial,
investigated the efficacy and safety of Zydelig in combination with
rituximab in patients with previously treated CLL. The Phase 2 101-09
study assessed the efficacy and safety of Zydelig in patients with iNHL
who are refractory to rituximab and alkylating agents. Results of Study
116 and Study 101-09 were published in The
The most commonly reported adverse reactions (incidence ≥20 percent) were diarrhea, pyrexia, fatigue, nausea, cough, abdominal pain and chills. Additionally, grade 3 or 4 elevations in ALT and AST (indicators of liver function) have been observed in clinical trials of Zydelig. Grade 3 or 4 pneumonitis and Grade 3 or 4 diarrhea/colitis were also observed in some patients in the clinical trials.
Zydelig is an investigational product and its safety and efficacy have
not been established in the
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.
For more information on
Gilead Sciences, Inc.
Patrick O’Brien, Investors
Arran Attridge, Media (EU)
+44(0)20 8587 2477
Nathan Kaiser, Media (US)