Gilead Sciences (NASDAQ:GILD) Issues Update on Zydelig as Treatment for iNHL, CLL
Gilead Sciences (GILD) announced long-term follow-up results from the registration studies further describing the duration of response, progression-free survival (NYSE:PFS) and safety profile for Zydelig (idelalisib) in relapsed patients with chronic lymphocytic leukemia (CLL) and two types of indolent non-Hodgkin lymphoma (iNHL). The findings are being presented this week at the Annual Meeting of the American Society of Hematology (NYSE:ASH).
Zydelig is indicated in the United States as monotherapy for patients with relapsed follicular B-cell non-Hodgkin lymphoma (NYSE:FL) and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies, and in combination with rituximab for patients with relapsed CLL for whom rituximab alone would be considered appropriate therapy due to comorbidities. Accelerated approval was granted for FL and SLL based on overall response rate; improvement in patient survival has not been established.
Indolent NHL and CLL are slow-growing, incurable blood cancers occurring typically in older individuals and can lead to life-threatening complications such as anemia, serious infection and bone marrow failure. Relapse commonly occurs after initial chemoimmunotherapy and many patients with relapsed disease are unable to tolerate chemotherapy, which may limit their treatment options.
"The results presented this week demonstrate the long-term benefit of Zydelig in patient populations that often have limited or no treatment options due to age or lack of response to existing therapies," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "As part of our ongoing effort to further define the safety and efficacy profile of Zydelig, we are continuing to pursue long-term follow-up studies and larger Phase 2 and Phase 3 clinical trials in combination with existing treatment regimens in both relapsed and first-line CLL and iNHL."
Disclosure: The author is long GILD.