NICE Recommends Bristol Myers Squibb’s Opdivo for Invasive Urothelial Cancer

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Bristol Myers Squibb’s Opdivo (nivolumab) for National Health Service (NHS) use in the adjuvant treatment of certain adult patients with muscle-invasive urothelial cancer that is at high risk of recurrence following radical resection whose tumors express programmed death-ligand 1 at one percent or more.

Specifically, the approval is for this patient population if adjuvant treatment with platinum-based chemotherapy is unsuitable.

The recommendation was based on clinical trial evidence showing that adjuvant treatment with Opdivo reduces the risk of the cancer returning compared with placebo. However, there is no data to show whether Opdivo increases how long people live.

The recommended dose of Opdivo for this indication is intravenous administration of 240 mg every two weeks over 30 minutes or 480 mg every four weeks over 60 minutes.

The UK list price of Opdivo is more than $3,130 dollars per 240 mg. The negotiated price for NHS use was not disclosed.