US FDA grants approval for BMS’ Opdivo for melanoma

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) to treat stage IIB or IIC melanoma patients who have undergone complete resection.

Opdivo is indicated for usage as adjuvant therapy in adult and paediatric individuals aged 12 years and above.

The approval is based on findings from the Phase III CheckMate-76K clinical trial of Opdivo versus placebo.

Trial data showed that Opdivo treatment offered a 58% decline in recurrence risk, in the occurrence of new primary melanoma and in mortality, compared to placebo.

The recurrence-free survival (RFS) rate was 89% for Opdivo and 79% for placebo at one year.

Bristol Myers Squibb US cardiovascular, immunology and oncology senior vice-president and general manager Catherine Owen stated: “This approval builds on our existing adjuvant indication in completely resected stage III or IV disease and now provides eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option which may help prevent recurrence.

“BMS remains committed to its goal of helping improve patient outcomes in melanoma and bringing immunotherapy to more patients, including in the earlier stages of disease.”

Opdivo is already approved by the FDA as adjuvant treatment in patients aged 12 years and above with melanoma that involves lymph nodes or metastatic disease following surgical resection.

In August 2023, the company received approval from the European Commission for Opdivo as an adjuvant treatment for the same indication.