The U.S. Food and Drug Administration today approved
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.
“Opdivo provides an important therapy option for patients
with renal cell carcinoma,” said Richard Pazdur, M.D., 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.” Torisel (temsirolimus), approved in 2007, is the only other
FDA-approved therapy that has demonstrated overall survival in renal cell
cancer.
Renal cell carcinoma is the most common form of kidney
cancer in adults and forms in the tissues of the kidney that make urine. The
National Cancer Institute estimates 61,560 new cases and 14,080 deaths from
kidney and renal pelvis cancer in the United States this year.
“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 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. 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 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.
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.
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.
Source: FDA web
page