FDA Approves Nivolumab for the Treatment of Advanced Renal Cell Cancer

It is intended for use in patients who have received a prior anti-angiogenic therapy

On 23 November, 2015 the US Food and Drug Administration (FDA) approved nivolumab (Opdivo) to treat patients with advanced (metastatic) renal cell carcinoma, who have received a prior anti-angiogenic therapy.

“Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.” Temsirolimus (Torisel), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer.

“Additionally, Opdivo’s extended indication, from melanoma and non-small cell lung cancer to renal cell cancer, demonstrates how immune therapies can benefit patients across a wide range of tumors,” continued Dr Pazdur.

Opdivo is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2. By blocking the PD-1/PD-L1 pathway, Opdivo may help the body’s immune system fight cancer cells. Opdivo is intended for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

The safety and efficacy of Opdivo for this use were demonstrated in an open-label, randomised study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agent. Patients were treated with Opdivo or everolimus (marketed as Afinitor).

Patients treated with Opdivo had a median overall survival of 25 months compared to 19.6 months in those treated with Afinitor. This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumours. Additionally, 21.5% of those treated with Opdivo experienced a complete or partial shrinkage of their tumours, which lasted an average of 23 months, compared to 3.9% of those taking Afinitor, lasting an average of 13.7 months.

The most common side effects of Opdivo for this use are asthenic conditions, cough, nausea, rash, dyspnoea, diarrhoea, constipation, decreased appetite, back pain and arthralgia.

Opdivo also has the potential to cause severe immune-mediated side effects that involve healthy organs.

The FDA granted the Opdivo application a breakthrough therapy designation, fast track designation, and priority review status. These are distinct programmes intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions.

Opdivo is marketed by Bristol-Myers Squibb based in Princeton, New Jersey.

Torisel is marketed by Pfizer, based in New York, New York.

Afinitor is marketed by Novartis Pharmaceuticals of East Hanover, New Jersey.