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The FDA granted approval to Opdivo as an adjuvant treatment in patients with high-risk urothelial carcinoma.
The Food and Drug Administration (FDA) approved Opdivo (nivolumab) on Friday as an adjuvant treatment for patients with urothelial carcinoma (UC) who have high risk of recurrence after undergoing radial resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
“This approval is a major milestone for patients who have undergone major surgery to remove the bladder or parts of the urinary tract and are in need of additional treatment approaches that can help reduce the risk of their UC returning,” said Dr. Matthew D. Galsky, professor of medicine, director of genitourinary medical oncology, co-director of the Center of Excellence for Bladder Cancer and associate director for translational research at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai, New York, in a news release.
Data from the phase 3 trial compared the effects of Opdivo with a placebo. Patients who received Opdivo had median disease-free survival (DFS, the amount of time that a patient has no evidence of disease on scans following surgery and is still alive) that was nearly twice as long as patients receiving the placebo. Opdivo also reduced risk of disease recurrence or death by 30% compared with the placebo.
“(Opdivo) provides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate-274 and has the potential to become a new standard of care option in this setting,” Galsky, who is also a primary investigator on the trial, said.
Among patients in the trial, 18% had to discontinue Opdivo and 33% had to delay it due to side effects. Serious reactions occurred in 30% of patients receiving the treatment, with the most frequent reaction being a urinary tract infection. Fatal side effects occurred in 1% of patients, which included pneumonitis. The most common side effects were rash, fatigue, diarrhea, pruritus, musculoskeletal pain and urinary tract infection.
“UC is the third type of cancer where Opdivo has been the first approved PD-1 inhibitor in the adjuvant setting,” Adam Lenkowsky, senior vice president and general manager of U.S. Cardiovascular, Immunology and Oncology at Bristol Myers Squibb, said in the announcement. “Now with this advancement, we can offer new hope to the conversations between healthcare providers and their UC patients where historically no approved treatment options have existed to help prevent disease recurrence post-surgery.”
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