Bristol-Myers Squibb (BMS) has obtained approval from US Food and Drug Administration (FDA) for its Opdivo (nivolumab) injection, for intravenous use.
Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody, which is indicated to treat patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMS noted the indication received accelerated approval based on tumour response rate and durability of response.
Bristol-Myers Squibb CEO Lamberto Andreotti said: "Bristol-Myers Squibb is pleased to be able to offer an important new option for patients who have progressed following treatment for unresectable or metastatic melanoma, which is one of the most aggressive forms of cancer.
"The approval of Opdivo, the latest breakthrough medicine from our immuno-oncology pipeline, demonstrates our company’s commitment to meeting the needs of these patients, and to leading advances in the science of immuno-oncology."
According to the company, Opdivo demonstrated efficacy in a Phase III pivotal clinical trial with advanced melanoma in patients who were previously treated and progressed with Yervoy and, if BRAF mutation positive, a BRAF inhibitor.
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Efficacy was assessed based on a single-arm and non-comparative planned interim analysis of the first 120 patients who received Opdivo, with a minimum of six months follow-up in the Phase III CheckMate -037 trial.
The company plans to begin shipping Opdivo within one to two weeks.
Image: Lymph node with almost complete replacement by metastatic melanoma. Photo: courtesy of Gabriel Caponetti.