Gilead Sciences Withdraws Trodelvy for Bladder Cancer

(Reuters) – Gilead Sciences announced on Friday the voluntary withdrawal of its drug, Trodelvy, intended for patients with a type of bladder cancer. This decision comes after the drug failed to meet the primary goal in a confirmatory trial.

The company stated that this decision was made in consultation with the U.S. health regulator, the Food and Drug Administration (FDA).

Trodelvy had received accelerated approval in 2021 for previously treated patients with metastatic urothelial cancer, with its ongoing approval relying on confirmatory trial results. Unfortunately, the trial showed that Trodelvy did not improve survival rates for patients with advanced bladder cancer.

Additionally, the study revealed a higher number of deaths linked to complications associated with Trodelvy when compared to patients receiving alternative therapies.

Trodelvy, classified as an antibody-drug conjugate, aims to target cancer cells specifically, potentially reducing damage to normal cells, unlike conventional chemotherapy.

However, the withdrawal of Trodelvy for bladder cancer does not affect its approval for other patient groups, including those within or outside the U.S., according to the company.

The drug remains approved in the U.S. for previously treated patients with advanced breast cancer where bladder cancer usage accounts for roughly 10% of Trodelvy's sales, totaling just over $1 billion in 2023.

Gilead is currently investigating Trodelvy in over 20 clinical trials for potential use in treating lung and gynecological cancers.

Following this announcement, Gilead’s shares dropped 1.4% to $86.16 in early trading.