- PMLiVE
AstraZeneca (AZ) has announced that its Imfinzi (durvalumab) perioperative regimen has been approved by the US Food and Drug Administration (FDA) to treat adults with muscle-invasive bladder cancer (MIBC).
The regulator has approved Imfinzi in combination with gemcitabine and cisplatin chemotherapy as a neoadjuvant treatment prior to bladder removal surgery (radical cystectomy), followed by Imfinzi as an adjuvant monotherapy after surgery.
More than 614,000 people are diagnosed with bladder cancer globally every year and MIBC, named for its growth into the muscle wall of the bladder, accounts for about one in four cases.
Approximately half of patients who undergo bladder removal surgery experience disease recurrence, and treatment options that prevent disease recurrence after surgery are “critically needed,” according to AZ.
Imfinzi is designed to attach to, and block the effects of, PD-L1, which is present on the surface of many cancer cells. This increases the ability of the immune system to attack the cancer cells and slows down disease progression.
The drug is already approved in the US to treat certain cases of lung cancer, biliary tract cancer, endometrial cancer and hepatocellular carcinoma.
The FDA’s latest decision, which makes Imfinzi the first and only perioperative immunotherapy approved in the US for MIBC, was based on positive results from the phase 3 NIAGARA trial.
The Imfinzi regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death compared to neoadjuvant chemotherapy before radical cystectomy.
AZ’s regimen was also shown to reduce the risk of death by 25% compared to neoadjuvant chemotherapy with radical cystectomy, and an estimated 82.2% of patients receiving the regimen were alive at two years compared to 75.2% in the comparator arm.
Dave Fredrickson, executive vice president, oncology haematology business unit, AZ, said: “[This] approval for Imfinzi represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with MIBC and addressing a significant need for better treatment options.
“The NIAGARA trial showed more than 80% of patients were still alive at two years, underscoring the potential of this innovative perioperative regimen to become a new standard of care in this setting.”