An intravenous line in a hospital file photograph. Illustrative image, not a VOLGA trial participant or the approved medicines. Photo: Tima Miroshnichenko / Pexels.
The Food and Drug Administration approved a new treatment plan Friday for adults whose bladder cancer has grown into the muscle wall and who cannot receive, or have declined, chemotherapy containing cisplatin.
Patients receive AstraZeneca’s Imfinzi, also called durvalumab, together with enfortumab vedotin-ejfv before surgery to remove the bladder. After surgery, they continue Imfinzi alone. The approval does not replace the operation.
The decision gives this group of patients another drug treatment to use around surgery. It is based on the VOLGA trial, which found that the combination improved both the time patients lived without a defined cancer-related event and overall survival compared with bladder-removal surgery alone.
VOLGA randomly assigned 695 patients to three groups. One received the newly approved treatment plan, another had surgery alone, and a third received a different experimental drug combination. The FDA’s approval covers the Imfinzi and enfortumab vedotin-ejfv plan, not that third regimen.
For the approved combination, the risk of an event in the trial’s main measure was 49% lower than with surgery alone over the period studied. The risk of death was 42% lower. These are relative reductions, not the percentage of patients cured or the number of extra years an individual patient can expect to live.
The median time before an event was 12.1 months in the surgery-only group. That median had not been reached in the combination group, meaning fewer than half of those patients had experienced an event at the analysis. Median overall survival had not been reached in either group.
The treatment also carries risks. The FDA lists immune-system reactions that can affect the body’s organs, reactions during an infusion and harm to an unborn baby among Imfinzi’s warnings. Common problems with the combination included rash, itching, fatigue, diarrhea, urinary tract infections, nerve symptoms and changes in blood and laboratory tests.
The approved schedule calls for three treatment cycles before surgery, followed by Imfinzi alone every four weeks for up to nine cycles afterward. Treatment can stop earlier if the cancer progresses so that definitive surgery is no longer possible, comes back or treatment side effects become unacceptable, according to the FDA.
The agency completed its review six weeks before its target date. It reviewed the application through Project Orbis with regulators in several other countries, including Israel. The FDA cautioned that applications in partner countries may still be under review. The U.S. decision does not establish approval elsewhere.
The indication and trial findings are set out in the FDA’s November 13 approval notice.
JBizNews Desk | New York
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