Today, the U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s nivolumab (Opdivo) as monotherapy in the adjuvant treatment of patients with completely resected stage IIB or IIC melanoma. FDA approval was based on results from the pivotal Phase 3 CheckMate -76K trial, in which nivolumab demonstrated a statistically significant and clinically meaningful recurrence-free survival (RFS) benefit compared to placebo. There is. Additionally, the safety profile of nivolumab was consistent with previously reported studies.1
“We hope that nivolumab can help patients reduce their chances of recurrence and live longer. The overall excellent safety profile allows patients to live longer with a better quality of life.” Dual Certification said Dr. Aaron Furberg, a dermatologist, Mohs surgeon, and chief medical director of Baer Dermatology in Dallas, Texas. Dermatology Times.
Secondary endpoints of the Phase 3 CheckMate -76K trial included overall survival, distant metastases-free survival, progression-free survival on next treatment, and safety endpoints.
Dr. Farbeg continued, “The question of managing completely resected stage IIB/C melanoma is a question of cure or remission. Unfortunately, once a patient is diagnosed with cancer, many years of It is difficult to say definitively that the cancer has been completely removed because the cancer is monitored to make sure it doesn’t come back because no one wants to be divided into groups like most cancers are staged. , it is important to understand each patient’s individualized risk. Once you understand a patient’s true personalized risk, you will be able to provide risk-tailored monitoring and management.
In July 2024, nivolumab became the world’s first PD-1 immune checkpoint inhibitor to receive regulatory approval, according to a news release. In addition, the nivolumab clinical development program has treated more than 35,000 patients to date.
“After a melanoma is surgically removed, patients may believe they don’t have the disease,” says Dr. Emerita, professor emeritus at the University of Pittsburgh School of Medicine and co-director of the Melanoma Center at UPMC Hillman Cancer Center. said one John M. Kirkwood, MD. .1 “However, within five years of diagnosis, one-third of patients with surgically resected stage IIB and nearly half of patients with surgically resected IIC melanoma experience cancer recurrence. ”, highlighting the need for additional treatment options to help reduce the risk of cancer recurrence. The significant recurrence-free survival improvement observed with nivolumab in CheckMate -76K is an important advance for these patients. ”
- The U.S. Food and Drug Administration has approved Bristol-Myers Squibb’s nivolumab for Opdivo (nivolumab) for the adjuvant treatment of patients with completely resected stage IIB or stage IIC melanoma. Bristol-Myers Squibb Company. news release. October 13, 2023. Accessed October 13, 2023. https://news.bms.com/news/corporate-financial/2023/US-Food-and-Drug-Administration-Approves-Opdivonivolumab-as-Adjuvant-Treatment-for – Completely excised Stage IIB or Stage IIC Eligible patients for melanoma 1/default.aspx