Published on April 21, 2021
Trodelvy Approved for Metastatic Bladder Cancer Treatment
The Food and Drug Administration (FDA) has granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy) for patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer that can have a poor prognosis. This treatment option is targeted at bladder cancers that have been previously treated with other therapies and whose cancer has gotten worse or spread.
Bladder cancer occurs when cells in the bladder develop changes in their DNA, causing cells to grow and divide uncontrollably. Acquired mutations, not inherited ones, are frequently the cause of bladder cancer. These mutations come from exposure to certain chemicals, such as those in tobacco smoke, that end up in the urine.
An estimated 83,730 Americans will be diagnosed with bladder cancer this year. Bladder cancer is often diagnosed early because, in many cases, it causes obvious symptoms such as blood in the urine (hematuria) and lower back pain.
Survival rates for bladder cancer are high overall, with a 5-year survival rate of 77%, according to the National Cancer Institute. But for those patients with distant-stage bladder cancer, which includes those with metastatic bladder cancer, the 5-year survival rate is just 6%.
The FDA granted accelerated approval for Trodelvy based on the tumor response rate and the duration of response demonstrated in a multicenter clinical trial called TROPHY. Continued approval for this drug may depend on the amount of clinical benefit in a follow-up trial, according to the FDA.
About the TROPHY Trial
The TROPHY trial, led by a research team from New York-Presbyterian/Weill Cornell Medical Center, was a single-arm study that enrolled 112 patients with locally advanced or metastatic urothelial cancer who had previously received a platinum-containing chemotherapy (eg, cisplatin, carboplatin, oxaliplatin) and either a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor — immunotherapies that harness the power of the immune system to kill cancer cells.
Participants received intravenous Trodelvy at a dose of 10 mg/kg on the first and eighth day of a 21-day treatment cycle.
The effectiveness of the drug was determined by looking at the objective response rate, which assesses the tumor response to treatment and the duration of response.
The confirmed objective response rate was 27.7%, with 5.4% of patients achieving complete responses to therapy and 22.3% with partial responses. The median duration of response was 7.2 months among 31 participants. This means that the treatment was effective for patients for about 7.2 months before disease progression.
Only a fraction of patients has long-term benefit from the previously approved therapies, “leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies,” Scott T. Tagawa, MD, an oncologist at New York-Presbyterian/Weill Cornell Medical Center, said in a statement. Dr. Tagawa was the principal investigator for the TROPHY trial.
“The response rate and tolerability seen with sacituzumab govitecan-hziy may provide physicians an effective new treatment option for patients whose cancer continues to progress even after multiple therapies,” Dr. Tagawa added.
The current standard of care is systemic chemotherapy. Patients whose cancer continues to progress are candidates for this new therapy.
Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network, praised the accelerated approval. “Bladder cancer patients need as many treatment options as possible,” she said in a statement.
Common Side Effects of Treatment
The treatment is considered safe overall, but has some side effects. The common side effects, occurring in more than 25% of participants in the TROPHY trial, included neutropenia (low white blood cell count), nausea/vomiting, diarrhea, fatigue, alopecia (hair loss), anemia, constipation, decreased appetite, rash, and abdominal pain.
Side effects leading to treatment discontinuation occurred in 10% of trial participants receiving Trodelvy, with 4% discontinuing the drug because of low white blood cell count.
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- US Food and Drug Administration. FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer. Published April 13, 2021.
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