FDA fast-tracks Opdivo for treatment of advanced kidney cancer
“Opdivo provides an important therapy option for patients with renal cell carcinoma,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.”
The most frequently diagnosed form of kidney cancer, renal cell carcinoma and other renal and pelvic kidney cancers will cause 14,080 deaths this year, statistics from the National Cancer Institute indicate.
"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,” Pazdur said.
The drug is indicated for use by patients who have had previous, unsuccessful anti-angiogenic therapies.
Opdivo was the subject of a randomized study of 821 advanced renal cell carcinoma patients whose condition had not responded to anti-angiogenic treatments. Patients treated with Opdivo survived 25 months after treatment compared to patients who received other treatments, who lived an average of 19.6 months. Tumors from 21.5 percent of the patients treated with Opdivo shrank or were eradicated, compared to a 3.9 percent rate for patients who used other treatments.
Opdivo's FDA application has been given fast-track designation and priority review status.
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