Bristol Myers Squibb has announced that the FDA has granted approval for Opdivo® (nivolumab) as an adjuvant treatment for individuals aged 12 and above who have undergone complete resection of stage IIB or IIC melanoma. In the cutaneous oncology domain, this is an epoch-making moment.
The approval is founded on the Phase 3 CheckMate -76K study, which compared Opdivo (n=526) to a placebo group (n=264). The primary focus of this trial was to evaluate recurrence-free survival (RFS) as assessed by the investigator. Secondary endpoints encompassed overall survival (OS), distant metastasis-free survival (DMFS), progression-free survival through next-line therapy (PFS2), and safety.
Catherine Owen, the Senior Vice President and General Manager of U.S. U.S. Commercialization, Cardiovascular, Immunology, and Oncology at Bristol Myers Squibb, stated that individuals with stage IIB and IIC melanoma still confront the risk of disease recurrence despite the benefits of surgery, potentially affecting their overall outcomes. She pointed out that this FDA approval expands upon Bristol Myers Squibb’s existing adjuvant indication for completely resected stage III or IV disease. It now offers eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option aimed at reducing the likelihood of recurrence.
Source: U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma.
https://news.bms.com/news/details/2023/U.S.-Food-and-Drug-Administration-Approves-Opdivonivolumab-as-Adjuvant-Treatment-for-Eligible-Patients-with-Completely-Resected-Stage-IIB-or-Stage-IIC-Melanoma1/default.aspx
