NICE and the SMC made their decisions after consulting the results of the Phase III TOPAZ-1 trial, which showed that adding durvalumab to gemcitabine and cisplatin increases how long people with biliary tract cancers live and extends the time before their cancer progresses.
The trial randomly assigned 685 patients to receive durvalumab alongside gemcitabine and cisplatin, or gemcitabine and cisplatin with a placebo. Estimates based on the results suggest that adding durvalumab could more than double two-year overall survival, although the exact extent of the improvement is unclear.
Durvalumab is delivered to the blood using a drip. It stimulates the body’s immune system to fight cancer cells by seeking out cells with a protein called PD-L1 on their surface and attaching to them. The immune system then recognises the marked cells and kills them.
The treatment was licenced through Project Orbis, an international programme to review and approve promising cancer drugs so patients can access innovative treatments faster.
NICE decisions are usually adopted in Wales and Northern Ireland, so durvalumab is likely to be offered to patients across the whole of the UK.
