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.
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