Gilead pulls cancer accelerated approval indications

Jan. 26, 2022

Gilead Sciences is pulling two indications for its cancer drug Zydelig as more treatments have become available in the market.

In 2014, Zydelig was approved as the first PI3K inhibitor by the U.S. FDA with the intended use of treating various B-cell blood cancers, including chronic lymphocytic leukemia (CLL). The drug was granted accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL). 

Since then, ongoing approval was based on continued evidence that would support the benefit of FL and SLL in patients. In the evolving treatment landscape, finding participants for the study has been challenging leading to the company’s decision to withdraw the indications from the U.S. market, said Gilead in a press release. 

Competitors include Bayer's Aliqopa, TG Therapeutics' Ukoniq and AbbVie and Johnson & Johnson’s BTK inhibitor, Imbruvica, which was granted FDA approval in 2016. Bayer was able to do what Gilead could not and combine Aliqopa with Roche’s Rituxan to reduce the risk of disease progression or death by 48% over Rituxan alone in patients. Aliqopa received FDA approval to treat FL in 2017. In 2016, Gilead attempted Rituxan combo trials but they were quickly stopped after reports of serious complications. 

Zydelig will remain on the market for CLL treatment in the U.S. The drug will not lose market approval to treat CLL and FL in the E.U., U.K., Canada, Australia, New Zealand and Switzerland.