News Briefs: Gilead Withdraws Two Zydelig Indications

Gilead Sciences, Inc. said on Jan. 14 that it is voluntarily withdrawing two indications for Zydelig (idelalisib): for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic leukemia (SLL), both of which had accelerated approval. “As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” said the company in a press release. Along with the FL and SLL approvals on July 23, 2014, the FDA granted traditional approval to the drug for the treatment of relapsed chronic lymphocytic leukemia. Zydelig will remain on the U.S. market for this indication.

Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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