FDA approved immunotherapy drug Opdivo to treat kidney cancer24 Nov 2015
The U.S. FDA has approved Bristol-Myers Squibb's immunotherapy drug Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. According to Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, Opdivo is one of few therapies that have demonstrated the ability to extend patients' survival in treating this disease.
Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (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. Bristol-Myers Squibb has reported that previous clinical results indicate that Opdivo is the first so-called immune checkpoint inhibitor drug to show an improvement in overall survival in patients with this type of kidney cancer. (link)
Opdivo is intended for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy (treatments that interfere with the blood vessels that contribute to the growth of cancerous cells).
Positive patient outcomes leading to FDA’s approval
The safety and efficacy of Opdivo for this use were demonstrated in an open-label, randomized 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 another type of kidney cancer treatment called everolimus (marketed as Afinitor). After analysis of the clinical results, researchers reported that:
- Those treated with Opdivo lived an average of 25 months after starting treatment 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 tumors.
- 21.5% of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to 3.9% of those taking Afinitor, lasting an average of 13.7 months.
Possible side effects of the drug
The most common side effects of Opdivo for this use are conditions relating to abnormal weakness or lack of energy (asthenic conditions), cough, nausea, rash, difficulty breathing (dyspnea), diarrhea, constipation, decreased appetite, back pain and joint pain (arthralgia).
Opdivo also has the potential to cause serious side effects that result from the immune system effect of Opdivo (known as "immune-mediated side effects"). These severe immune-mediated side effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain.
The FDA granted the Opdivo application a breakthrough therapy designation, fast track designation, and priority review status. These are distinct programs 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.
Source: Medical News Today