Today, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the adjuvant treatment of patients with melanoma that has involvement of lymph nodes or metastatic disease, and who have undergone complete resection.
Today, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the adjuvant treatment of patients with melanoma that has involvement of lymph nodes or metastatic disease, and who have undergone complete resection. Nivolumab is the first and only anti-programmed death (PD)-1 immune checkpoint inhibitor that is approved for adjuvant treatment of melanoma, and is indicated for both BRAF mutant and wild type patients.
In the phase 3 CheckMate-238 trial, nivolumab significantly improved recurrence-free survival (RFS) versus ipilimumab (Yervoy, Bristol-Myers Squibb), in patients with stage III/C or stage IV melanoma after surgery. This result was observed across multiple subgroups, including both BRAF mutant and BRAF wild-type patients.
“Today’s approval builds on our leadership in melanoma, offering physicians a new option with the potential to change the course of the disease through earlier intervention. Opdivo is the first PD-1 inhibitor approved as an adjuvant treatment for any cancer,” said Johanna Mercier, head, US commercial, Bristol-Myers Squibb. “Our decision to study Opdivo versus Yervoy—an established standard of care with a proven survival benefit—represents our relentless pursuit to bring more effective treatments to patients.”
Opdivo demonstrated an 18-month RFS rate of 66.4% (95% CI: 61.8 to 70.6) compared with 52.7% for Yervoy (95% CI: 47.8 to 57.4), with the median RFS not yet determined in either group. Opdivo reduced the risk of disease recurrence by 35% versus Yervoy (hazard ratio [HR]: 0.65; 95% CI: 0.53 to 0.80; p <0.0001).
In September 2017, nivolumab received “Breakthrough Therapy Designation” from the FDA for the adjuvant treatment of patients with high-risk, fully resected melanoma.
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
Empowering Community Health Through Wellness and Faith
April 23rd 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. In the third episode, Camille Clarke-Smith, EdD, MS, CHES, CPT, discusses approaching community health holistically through spiritual and community engagement.
Listen
Insurance Coverage Limits JAKi Therapy Access for Patients With AA, Especially Non-White Populations
April 25th 2024A survey study showed major barriers to Janus kinase inhibitor (JAKi) therapy for patients with alopecia areata, especially for non-White patients who face higher rates of being uninsured and struggle more to afford the treatment.
Read More