Bristol-Myres Squid’s Opdivo gets FDA’s nod (kidney cancer)November 24, 2015
The U.S. Food and Drug Administration has approved Bristol-Myers Squibb-marketed Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, which is a form of kidney cancer, who have received a certain type of prior therapy.
On Tuesday, Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research explained that Opdivo provides an important therapy option for patients with renal cell carcinoma.
He says it is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease, which is the most common form of kidney cancer in adults and forms in the tissues of the kidney that make urine.
Prior to this, the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer was Pfizer-marketed Torisel (temsirolimus), approved in 2007.
“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.
Francis Cuss, Bristol-Myers’ CEO pointed out that this is the fifth approval for Opdivo across three distinct tumor types.
In October, the FDA approved Opdivo for treating small lung cell cancer patients whose condition worsened by receiving chemotherapy treatment
Bristol-Myers Squib said that Tuesday’s announcement marks the approval of the first and only PD-1 inhibitor to deliver significant overall survival (OS) in patients with advanced RCC who have received prior anti-angiogenic therapy.
With the FDA approval of Opdivo, the kidney cancer community is now a step closer toward achieving long-term survival, which has remained elusive for many patients, said Robert J. Motzer, M.D., medical oncologist, Memorial Sloan Kettering Cancer Center.
How Opdivo works?
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. 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).
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.
According to FDA, patients were treated with Opdivo or another type of kidney cancer treatment called everolimus, marketed as Afinitor. Those treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with Novartis-marketed Afinitor.
This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors. Additionally, 21.5 percent 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 percent of those taking Afinitor, lasting an average of 13.7 months.
FDA explained that the most common side effects of Opdivo are fatigue, musculoskeletal pain, decreased appetite, cough and constipation. 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.