Opdivo approved for patients with metastatic renal cell carcinoma

November 25, 2015

FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients with metastatic renal cell carcinoma.

FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients with metastatic renal cell carcinoma.

Renal cell carcinoma is the most common form of kidney cancer in adults and develops when malignant cells form in the lining of the tubules of the kidney.  Patients with renal cell carcinoma may not exhibit symptoms early on in the disease; however in the later stages, signs and symptoms may include blood in the urine, back or side pain, loss of appetite, and anemia. The National Cancer Institute estimates that more than 60,000 new cases and more than 14,000 deaths from kidney and renal pelvis cancer in the United States this year.

Opdivo is an antineoplastic agent known as an anti-PD-1 (programmed cell death-1) monoclonal antibody that works by targeting the cellular pathway, PD-1/PD-L1, which includes proteins found on the body’s immune cells and some cancer cells. By blocking this pathway, Opdivo may help the body’s immune system fight cancer cells. Opdivo is now approved for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy. Anti-angiogenic therapy targets new blood vessels that provide oxygen and nutrients to actively proliferating tumor cells.

Related:FDA approves additional indication for Opdivo

The approval of Opdivo was based on an clinical study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agents. Patients were randomized to receive either Opdivo or everolimus (Afinitor, Novartis), another type of kidney cancer treatment. Results showed that those treated with Opdivo lived an average of 25 months after treatment initiation as compared to 19.6 months in those treated with Afinitor. Additionally, 21.5% of the Opdivo group experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to 3.9% of the Afinitor group, lasting an average of 13.7 months.

FDA granted Opdivo breakthrough therapy and fast track designations as well as priority review status. These programs are reserved for new drugs that show a potential to benefit patients with serious or life-threatening conditions.

The most common side effects associated with the use of Opdivo include weakness and lack of energy, cough, nausea, rash, dyspnea, and arthralgia. Opdivo may also cause serious immune-related side effects involving healthy organs such as the lungs, colon, liver, kidneys, endocrine glands, and the brain.

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