(Reuters) -Gilead Sciences said on Friday it was voluntarily withdrawing its drug, Trodelvy, for patients with a type of bladder cancer after it failed to meet the main goal in a confirmatory trial.
The decision was made in consultation with the U.S. health regulator, the company said.
The U.S. Food and Drug Administration had granted accelerated approval to Trodelvy for previously treated patients with metastatic urothelial cancer in 2021, while its continued approval was dependent on results of a confirmatory trial.
The drug failed to improve survival for patients with advanced bladder cancer in the trial.
There were also a higher number of deaths, associated with complications related to Trodelvy, in the study compared to the patient group that received another therapy chosen by their doctor. Gilead had said it was investigating this data.
Trodelvy is an antibody-drug conjugate, a class of treatments designed to target only cancer cells, unlike conventional chemotherapy, potentially reducing damage to normal cells.
The withdrawal, however, does not affect Trodelvy’s approval for other patients within or outside of the U.S., the company said.
The drug is approved in the U.S. for previously treated patients with a type of advanced breast cancer.
Trodelvy carries a boxed warning for neutropenia, a common condition among people receiving cancer treatments that results in lower-than-normal levels of a type of white blood cells.
Bladder cancer use accounts for about 10% of Trodelvy sales, which totaled just more than $1 billion in 2023.
Gilead is also testing the drug, alone and in combination with other therapies, in more than 20 clinical trials as a possible treatment option for lung and gynecological cancers.
Shares of the drugmaker fell 1.4% to $86.16 in early trading.
(Reporting by Sneha S K in Bengaluru; Editing by Shilpi Majumdar)
