The Food and Drug Administration has approved the use of Opdivo (nivolumab) for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The drug targets the PD-1/PD-L1 pathway to help the body's immune system fight cancer cells.
"Opdivo provides an important therapy option for patients with renal cell carcinoma," Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release. "It is one of few therapies that have demonstrated the ability to extend patients' survival in treating this disease.
"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," Pazdur added.
Torisel (temsirolimus), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer, the news release noted.
Other FDA Actions for Opdivo
Opdivo, marketed by Bristol-Myers Squibb, has previously received Priority Review and Breakthrough Therapy designations for this indication. And the drug is also approved for the treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) that has progressed during or after platinum-based chemotherapy (OT 11/25/15 issue); in combination with ipilimumab (marketed as Yervoy) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma (OT 11/10/15 issue); for the treatment of patients with squamous NSCLC that has progressed on or after platinum-based chemotherapy (OT 4/10/15 issue); and for the treatment of patients with unresectable or metastatic melanoma that no longer responds to other drugs (OT 1/25/15 issue).
Safety and Efficacy Data
Approval for Opdivo for this indication is based on data from the CheckMate 025 Phase III study of 821 patients with previously treated advanced RCC who received either Opdivo or everolimus (the current standard of care for patients with metastatic RCC, marketed as Afinitor). Patients treated with nivolumab had a median overall survival of 25 months compared with 19.6 months with everolimus. The trial was stopped early in July 2015 because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint of overall survival. Data from CheckMate 025 were recently presented at the 2015 European Cancer Congress and simultaneously published in The New England Journal of Medicine (OT 10/25/15 issue).
The most common side effects reported by patients who have taken Opdivo are asthenic conditions, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, back pain, and arthralgia. Opdivo also has the potential to cause serious immune-mediated side effects that affect the lung, colon, liver, kidneys, hormone-producing glands, and the brain, according to the FDA.
Clinical Quick Facts
Drug: Opdivo (nivolumab)
Approved Indication: Treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy
Serious Side Effects: Immune-mediated side effects that affect the lung, colon, liver, kidneys, hormone-producing glands, and the brain
Common Side Effects: Asthenic conditions, cough, nausea, rash, dyspnea, diarrhea, constipation, decreased appetite, back pain, and arthralgia