Gilead Sciences has obtained US Food and Drug Administration (FDA) approval for its Zydelig (idelalisib) 150mg tablets for treatment of three B-cell blood cancers.
Zydelig is an oral inhibitor of phosphoinositide 3-kinase (PI3K) delta and can be used to treat patients whose chronic lymphocytic leukemia (CLL) has returned (relapsed).
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Used in combination with rituximab, Zydelig is to be used in patients for whom rituximab alone would be considered appropriate therapy due to other existing medical conditions.
Zydelig was also granted accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). The drug is intended to be used in patients who have received at least two prior systemic therapies.
The accelerated approval for Zydelig was granted for FL and SLL based on overall response rate.
A principal investigator on the Zydelig pivotal Phase III trial in CLL Bruce Cheson said: "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.
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By GlobalData"In clinical studies among patients with relapsed CLL, FL and SLL, Zydelig produced strong responses, including a significant improvement in progression-free survival in CLL."
The FDA’s approval of Zydelig in CLL is based on data from a randomised, placebo-controlled Phase III trial of Zydelig plus rituximab in 220 patients with relapsed CLL, who were not able to tolerate standard chemotherapy.
The product’s accelerated approval in FL and SLL is based on data from a single-arm Phase II study of Zydelig monotherapy in patients refractory to rituximab and alkylating-agent-containing chemotherapy.
Image: FDA approved Zydelig for relapsed chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. Photo: courtesy of BusinessWire/Gilead Sciences, Inc.
