Introduction

The drug nivolumab (trade name: Opdivo) has been approved in Germany since June 2017 for the treatment of advanced urothelial carcinoma. The drug is an option for adults with urothelial cancer that is progressing despite platinum-based chemotherapy.

The word “urothelial” comes from the medical term for the type of membrane tissue lining the urinary tract (urothelium). The urinary tract includes the renal pelvis, the ureter, the urinary bladder and the upper part of the urethra. In more than 90 out of 100 people with a urothelial carcinoma, it develops in the bladder (bladder cancer).

The early symptoms usually include painless bleeding in the bladder, turning the urine a brownish color. People may also feel like they have to urinate more often. The symptoms of advanced urothelial carcinoma may include pain in the abdomen or kidneys, enlarged lymph nodes, or bone pain. It is more common in men than in women.

Nivolumab is used to treat advanced urothelial carcinoma that can no longer be surgically removed or that has already spread to other parts of the body (metastasis). The aim of treatment with this drug is to stimulate the immune system to fight the cancer.

Application

Nivolumab is given every two weeks in the form of an infusion (an IV drip), entering the bloodstream directly through a vein. The infusion takes about 60 minutes. The dose is based on the patient’s body weight (3 mg of the drug per kg of body weight).

The treatment is stopped if the disease gets worse or if very severe side effects arise.

Other treatments

For patients with advanced urothelial carcinoma who have had unsuccessful treatment with platinum-based chemotherapy, the drug vinflunine is an option. If the cancer comes back 6 to 12 months after chemotherapy (late relapse), another course of cisplatin-based chemotherapy can be considered.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether nivolumab has any advantages or disadvantages for people with advanced urothelial carcinoma when compared with the current standard treatments.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of nivolumab (Opdivo).