BMS Gains European Approval for Opdivo

Bristol Myers Squibb (BMS) has been granted approval by the European Commission (EC) for Opdivo (nivolumab) as an adjuvant treatment for adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease after prior neoadjuvant chemoradiotherapy (CRT).

EC’s decision was based upon the results of a Phase III clinical trial (CheckMate – 577), which demonstrated the efficacy and safety of the therapy. In the randomized, multicenter, double-blind trial, the patients that received Opdivo were found to have doubled disease-free survival rates compared with those patients who had been administered a placebo treatment.

“We have demonstrated that the use of immunotherapy in earlier stages of cancer has the potential to prevent recurrence for certain patients,” said Ian M. Waxman, MD, development lead, gastrointestinal cancers, Bristol Myers Squibb, in a July 30, 2021 company press release. “BMS was the first company to bring checkpoint inhibitors into the adjuvant setting for the treatment of patients with melanoma, and we are pleased to be the first to bring adjuvant therapy to patients in the EU with esophageal or gastroesophageal junction cancers who continue to face a high unmet need.”

Opdivo also was granted approval from the US FDA in May 2021.

Source: BMS