Astellas Pharma has welcomed final draft guidance from NICE recommending pembrolizumab (KEYTRUDA) in combination with enfortumab vedotin (PADCEV) as a treatment option for adults with muscle-invasive bladder cancer (MIBC) in England and Wales.
The recommendation covers use of the combination as neoadjuvant treatment before surgery, followed by continued treatment after radical cystectomy as adjuvant therapy, within its marketing authorisation.
According to Astellas, the decision provides a treatment option for eligible adults with MIBC regardless of whether they are able to receive cisplatin-based chemotherapy, which has traditionally been a standard treatment before surgery.
NICE concluded that there is sufficient evidence to demonstrate clinical benefit and cost effectiveness for the combination, supporting its routine use across the NHS in this patient population.
Bladder cancer is responsible for around 5,900 deaths annually in the UK and accounts for approximately 3% of all cancer deaths. Muscle-invasive bladder cancer is an aggressive form of the disease in which tumour cells spread beyond the bladder lining and into the surrounding muscle.
The condition is associated with a substantial risk of recurrence and disease progression despite treatment being given with curative intent. NICE has previously identified a need for treatments that can slow disease progression and prolong survival, particularly among patients who cannot receive cisplatin.
Dr Tim Patel, Medical Director at Astellas UK, said: “We welcome NICE’s recommendation for adults with muscle-invasive bladder cancer.”
He added: “This is an important step in expanding treatment options around surgery, including for people who are unable to receive cisplatin-based chemotherapy.”
Patel continued: “We remain committed to working with the NHS and the bladder cancer community to support timely access to treatment advances for patients who may benefit.”
PADCEV is an antibody-drug conjugate directed against Nectin-4, a protein highly expressed in bladder cancer cells. The therapy is already approved in several territories for urothelial cancer indications, including in combination with pembrolizumab.
In the EU, the combination of enfortumab vedotin and pembrolizumab is approved for adult patients with resectable muscle-invasive bladder cancer regardless of cisplatin eligibility.
