Gilead is withdrawing the accelerated approval for its blockbuster antibody-drug conjugate Trodelvy for bladder cancer after it failed to improve survival odds for patients in a Phase 3 study earlier this year.
The company decided to voluntarily pull the drug’s accelerated label after consulting with the FDA, according to Friday’s announcement.
Trodelvy’s bladder cancer indication makes up a small percentage of its overall sales since the drug is primarily used to treat breast cancer, but the withdrawal occurs amid mounting criticism of Gilead’s business decisions. Much of Wall Street’s concern centers around the company’s $21 billion buyout of Immunomedics in 2020 that brought it Trodelvy, a drug that generated $1.1 billion in sales last year and that Gilead has described as a “cornerstone” of its cancer portfolio.
The FDA in 2021 granted accelerated approval to Trodelvy for patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-based chemotherapy and a checkpoint inhibitor.
However, in May, Gilead disclosed that Trodelvy did not improve survival in bladder cancer patients compared to chemotherapy, and there were more deaths in the Trodelvy arm than the chemo control arm primarily due to infections from low white blood cell counts, a known serious side effect of the drug.
Gilead said it plans to share detailed bladder cancer data at an upcoming medical meeting.
Back in January, the company said Trodelvy also failed a pivotal study in non-small cell lung cancer, dealing a blow to its expansion plans for the antibody-drug conjugate. And earlier this year, Gilead recorded a $2.4 billion loss related to assets from the Immunomedics deal.
The company has stumbled as it has tried to build out its cancer pipeline. It spent $4.9 billion in 2020 to buy Forty Seven for its experimental CD47-targeted cancer drug, but the company this year stopped work on the drug, called magrolimab, after it failed to improve survival odds in pivotal blood cancer studies and came with worrying safety risks.
Gilead announced in July that its chief medical officer Merdad Parsey would be leaving in early 2025.