The FDA has just granted the Opdivo breakthrough therapy designation, to treat patients suffering from advanced metastatic renal cell carcinoma who have already received prior anti-angiogenic therapy (treatments that interfere with the blood vessels that contribute to the growth of cancerous cells). Renal cell carcinoma is the most common form of kidney cancer in adults and forms in the tissues of the kidney that make urine. According to The National Cancer Institute approximately 61,560 new cases and 14,080 deaths from kidney and renal pelvis cancer will have occurred in the US by the end of this year. The drug 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. Torisel (temsirolimus), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer.
“Opdivo provides an important therapy option for patients with renal cell carcinoma,” stated Dr. 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.”
The new approval now extends Opdivo’s indication, from melanoma and non-small cell lung cancer to renal cell cancer, and demonstrates how immune therapies can benefit patients across a wide range of tumors.
The safety and efficacy of the drug for use in treatingkidney cancer was 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% of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to just under 4% 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, cough, nausea, rash, difficulty breathing, diarrhea, constipation, decreased appetite, back pain and joint pain.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.
Although doctors don’t really know what causes renal cancer, those who smoke cigarettes and cigars are twice as liable to get the disease than non-smokers. Blacks also have a higher risk than whites, and men (in general) are twice as likely to get it than women. Other risk factors include obesity, long-term use of certain pain medications (both over-the-counter and prescription), having advanced kidney disease or being on long-term dialysis, having certain genetic conditions, such as von Hippel-Lindau (VHL) disease or inherited papillary renal cell carcinoma, a family history of kidney cancer, being exposed to certain chemicals, such as asbestos, cadmium, benzene, organic solvents, or certain herbicides, having high blood pressure, and having lymphoma.