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Gilead's Trodelvy fails to meet main goal in late-stage cancer study
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Gilead's Trodelvy fails to meet main goal in late-stage cancer study
May 30, 2024 3:03 PM

May 30 (Reuters) - Gilead Sciences ( GILD ) said on

Thursday its drug Trodelvy, tested in patients with bladder

cancer who previously received chemotherapy and other

anti-cancer therapies, did not meet the main goal of a

late-stage study.

The company said the drug did not meet the main goal of

overall survival.

In the overall study population, there was a higher

number of deaths due to adverse events with Trodelvy, which

belongs to a class of treatments known as antibody-drug

conjugates, compared to chemotherapy, Gilead said.

The deaths were primarily observed early in treatment

and related to neutropenic complications - that involve

lower-than-normal levels of a type of white blood cell -

including infection.

"There are no changes to the known safety profile of

Trodelvy for the approved breast cancer indications or other

investigational uses," the company said.

The drugmaker is continuing to analyze the data and will

discuss the results and next steps with the U.S. Food and Drug

Administration, it said.

Continued approval for this indication may be contingent

upon verification of clinical benefit in confirmatory trials,

including this late-stage trial, the California-based company

said.

The study tested the drug versus chemotherapy in

patients with metastatic urothelial cancer or bladder cancer.

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