FDA OKs BMS’ Immuno-Oncology Drug Combination

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for treating patients with BRAF V600 wild-type unresectable or metastatic melanoma. Opdivo and Yervoy are two immuno-oncology drugs from BMS. Opdivo and Yervoy are immune checkpoint inhibitors that target separate, distinct and complementary checkpoint pathways (PD-1 and CTLA-4).

BMS has a broad, global development program to study the combination of Opdivo and Yervoy consisting of more than 14 trials in which more than 2,000 patients have been enrolled worldwide through September 2015. The mechanism of action involves dual immune checkpoint inhibition resulting in increased anti-tumor activity. Yervoy’s blockade of CTLA-4 has been shown to augment T-cell activation and proliferation while Opdivo restores the active T-cell response directed at the tumor.

In the US, the FDA approved Opdivo for treating patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor in 2014. In March 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. In 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries.

Source: Bristol-Myers Squibb

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