BMS receives approval from FDA for Yervoy (ipilimumab) as adjuvant treatment for fully resected Stage III melanoma

First company to demonstrate the potential of an immune checkpoint inhibitor in the adjuvant treatment for these patients.

Resectable, Stage III melanoma represents 5%, or approximately 3,100 cases, of all new melanoma cases diagnosed annually. This stage of melanoma can be aggressive, with a 60% risk of recurrence after surgery. Despite the risk of disease recurrence among Stage III melanoma patients following resection, there are limited treatment options available to help reduce the risk of recurrence after surgery.

“The science of immuno-oncology is rapidly advancing, and we are proud to be the first to demonstrate the potential of an immune checkpoint inhibitor in the adjuvant setting, an earlier stage of the disease, where patients urgently need new medicines,” said Michael Giordano, senior vice president, head of Development, Oncology, BMS. “The approval of Yervoy for the treatment of adjuvant melanoma underscores our scientific leadership in immuno-oncology, with a commitment to further developing our I-O agents — Yervoy and Opdivo — across multiple tumour types and at many stages of disease.”

“Today’s approval is an important step in our commitment to bring our Immuno-Oncology pipeline to earlier lines of cancer treatment and to make new options available quickly while we continue to build upon our scientific understanding and develop even better solutions,” continued Giordano. “BMS has broad development programs in the adjuvant setting across multiple tumours, including the ongoing studies of Opdivo and of Yervoy in adjuvant melanoma.”