AstraZeneca PLC's (LSE:AZN) cancer drug Imfinzi has been approved in the European Union for use before and after surgery in patients with muscle-invasive bladder cancer, marking a significant step forward in treatment options for the disease.
The approval means Imfinzi is now the first and only immunotherapy authorised in Europe for use both before and after surgery, what doctors call “perioperative” treatment, in patients whose cancer has spread into the bladder muscle but is still operable.
The decision follows strong results from a major clinical trial, known as NIAGARA, which showed that patients receiving Imfinzi alongside chemotherapy before surgery and then continuing with the drug afterwards were less likely to see their cancer return, and more likely to survive.
Specifically, the trial noted a 32% reduction in the risk of the cancer coming back or worsening, and a 25% reduction in the risk of death, compared with patients who received chemotherapy and surgery alone.
After two years, about 82% of patients on the Imfinzi regimen were still alive, versus 75% in the comparison group.
Dr Michiel Van der Heijden of the Netherlands Cancer Institute, who worked on the trial, said nearly half of patients experience recurrence despite treatment with chemotherapy and surgery.
"The NIAGARA results showed how this regimen reduced the risk of recurrence by nearly a third and significantly extended survival,” he added.