AstraZeneca has received a positive recommendation from the National Institute for Health and Care Excellence for durvalumab, marking the first time a perioperative immune‑oncology treatment has been approved for cisplatin‑eligible patients with muscle‑invasive bladder cancer.
The decision follows results from the Niagara phase 3 trial, which showed that durvalumab improved overall survival, with 82.2% of patients alive at 24 months compared with 75.2% in the comparison group. The study also demonstrated a 25% reduction in the risk of death and a 32% reduction in the risk of progression compared with standard neoadjuvant cisplatin‑based chemotherapy.
Tom Keith‑Roach, Country President, AstraZeneca UK, said: “This positive NICE recommendation marks an important step forward for people living with one of the most aggressive forms of bladder cancer. The decision reinforces our commitment to bringing innovative medicine to those who need them most, as we continue working to eliminate cancer as a cause of death.”
Bladder cancer affects around 21,000 people each year in the UK and accounts for about 3% of all new cancer cases. Muscle‑invasive disease carries a high risk of recurrence and metastasis, with around half of patients experiencing recurrence or progression within five years of standard therapy.
Jeannie Rigby, CEO of Action Bladder Cancer, said: “Any cancer diagnosis has a profound impact – and a diagnosis of muscle‑invasive bladder cancer can be life‑changing. Too many patients are left with uncertainty, even after surgery, and can face a poor outcome. Access to innovative treatments that can improve survival is crucial. ABC UK and bladder cancer patients welcome this decision – the continued progress in bladder cancer care is vitally important.”
Dr Syed Hussain, Professor and Honorary Consultant in Medical Oncology at the University of Sheffield and Sheffield Teaching Hospitals NHS Trust, said: “Muscle-invasive bladder cancer remains a challenging disease to treat with a high risk of recurrence even after radical surgery and chemotherapy.
“The NIAGARA results are particularly important, as with the addition of peri operative Durvalumab, we see improved disease-free survival and overall survival. We see higher subset of patients achieving cure and I am delighted to see this has been made available for our patients by NICE and will be the new standard of care.”
