The regulator’s decision was based on results of CheckMate-141, a phase 3, open-label, randomized trial testing of Opdivo in comparison to three of the most commonly used treatments in patients with neck and head cancer that has progressed or worsened within six months of platinum therapies.
The trial was halted early this January after meeting its primary endpoint of overall survival.
Bristol-Myers Squibb global clinical research lead for oncology Jean Viallet said: "The Breakthrough Therapy Designation for Opdivo in advanced squamous cell carcinoma of the head and neck underscores the immediate need for new treatment approaches for this devastating disease, and reflects our commitment to advancing Immuno-Oncology research with the goal of addressing hard-to-treat cancers and changing survival expectations for patients."
Opdivo (nivolumab) targets the cellular pathway known as PD-1/PD-L1 proteins identified on the body’s immune cells and various cancer cells. The blocking of the pathway helps the body’s immune system fight cancer cells.
It is approved for single-agent treatment of patients with BRAF V600 wild-type and BRAF V600-positive unresectable or metastatic melanoma.
It is also approved to treat patients with metastatic non-small cell lung cancer that progressed on or after platinum-based chemotherapy, as well as for the treatment of patients with advanced renal cell carcinoma who received prior antiangiogenic therapy.
Image: Bristol-Myers Squibb facility in Syracuse, New York, US. Photo: courtesy of Bristol-Myers Squibb Company.