Gilead sign

Gilead’s bladder cancer drug gets FDA approval

pharmafile | April 15, 2021 | News story | |  FDA, Gilead, bladder cancer, bladder cancer treatment, pharma, pharma news 

The FDA have granted accelerated approval to Gilead’s Trodelvy drug for the treatment of metastatic urothelial cancer (UC).

The decision was based on data from the Phase II TROPHY study, of 112 patients, which found that 27.7% of those treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The median duration of response was just over seven months.

Trodelvy has been approved for use in adult patients with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy, and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor. 

The FDA’s accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint. Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial.

UC is the most common type of bladder cancer and occurs when the urothelial cells that line the inside of the bladder and other parts of the urinary tract grow unusually or uncontrollably. An estimated 83,000 Americans and 10,200 Brits are diagnosed with bladder cancer each year, and almost 90% of these diagnoses will be UC. The relative five-year survival rate for patients with metastatic UC is 5.5%.

Trodelvy is already approved in the US to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer, who have received two or more prior systemic therapies including one for metastatic disease.

Dr Scott T Tagawa, Professor of Medicine and Urology at Weill Cornell Medicine, and Principal Investigator of the TROPHY study, said: “Only a fraction of patients derive long-term benefit from previously approved cytotoxic therapy or immunotherapy, leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies.

“The response rate and tolerability seen with sacituzumab govitecan-hziy [Trodelvy] may provide physicians an effective new treatment option for patients whose cancer continues to progress even after multiple therapies.”

Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network, added: “Cases of urothelial cancer continue to rise in the US, yet prognosis remains the same for the vast majority of patients. Bladder cancer patients need as many treatment options as possible, and we are pleased that Trodelvy can be a potentially viable treatment for them.”

Jack Goddard

Related Content

FDA grants marketing authorisation to DNA test for predisposition to certain cancers

The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the …

Biogen’s biosimilar Tofidence approved by FDA

Biogen has announced that the US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) …


Karuna Therapeutics submits NDA to FDA for schizophrenia treatment

Karuna Therapeutics has announced that it has submitted a New Drug Application (NDA) to the …

Latest content