Gilead withdraws Zydelig indication for lymphoma, leukemia subtypes
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Gilead Sciences has decided to voluntarily withdraw its accelerated approval of idelalisib for two blood cancer indications.
The FDA in 2014 granted accelerated approval to idelalisib (Zydelig, Gilead Sciences) for treatment of relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic leukemia.
The agency based approval on results of a phase 2 study that showed 54% of patients with follicular lymphoma and 58% of those with small lymphocytic leukemia achieved objective response per independent review committee assessment.
Continued approval remained contingent on additional evidence supporting confirmation of clinical benefit in these patient populations.
“As the treatment landscape for [follicular lymphoma and small lymphocytic leukemia] has evolved, enrollment into the confirmatory study has been an ongoing challenge,” a Gilead-issued press release read. “As a result, [the company] formally notified the FDA of its decision to voluntarily withdraw these indications from the U.S. market.”
Idelalisib will remain on the market in the United States as part of combination treatment for patients with relapsed chronic lymphocytic leukemia. Approvals for CLL and follicular lymphoma in other countries are not affected by the proposed indication withdrawal.
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