NICE recommends Opdivo as post-surgery treatment

The therapy will be used for specific muscle invasive urothelial cancer patients

Bristol Myers Squibb has announced that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending Opdivo (nivolumab) for the adjuvant treatment of adult patients with muscle invasive urothelial carcinoma (MIUC).

It primarily involves individuals who are at high risk of recurrence following radical surgical resection and whose tumours express PD-L1 at a level of 1% or more. It is recommended only if adjuvant treatment with platinum-based chemotherapy is unsuitable.

The decision is supported by data from the phase 3 CheckMate-274 clinical trial, which demonstrated that at a minimum follow up of 11.4 months, over two-thirds of MIUC patients who received Opdivo as an adjuvant therapy following surgery were still alive and disease-free 12 months after randomisation, compared to 46.3% who received a placebo.

At a minimum follow-up of 5.9 months, Opdivo had a generally manageable safety profile in the intention-to-treat population of the study. Furthermore, exploratory analyses showed the quality of life of patients receiving Opdivo was maintained compared to those who received placebo, as measured through the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire.

Urothelial cancer occurs in the cells which form the inner lining of the bladder, urethra, ureter or renal pelvis, but most commonly occurs in the bladder. Approximately 10,300 people are diagnosed with bladder cancer in the UK every year, making it the eleventh most common cancer in the UK and the eighth most common cancer in men.

Invasive urothelial carcinoma is when cancerous cells spread beyond the lining into the surrounding bladder muscle and is normally treated by surgery to completely remove the bladder.

Meanwhile, urothelial carcinoma is the most common form of bladder cancer, accounting for more than 90% of cases in the UK but it can also occur in the renal pelvis or the ureter.

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