European Commission Approves Opdivo

July 21, 2015
BioPharm International Editors

The decision makes Bristol-Myers Squibb’s therapy the first PD-1 checkpoint inhibitor approved in Europe.

The European Commission approved Opdivo (nivolumab) on July 20, 2015 for the treatment of locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) after prior chemotherapy.

The approval was largely based on the trial results of CheckMate -017 and -063. In the Phase III CheckMate -017 study, Opdivo demonstrated superior clinical benefit across all endpoints versus docetaxel, the current standard of care. Opdivo demonstrated a 41% reduction in the risk of death and an overall survival rate that was significantly superior to docetaxel (42% and 24%, respectively). In the Phase II CheckMate -063 study, nivolumab showed an estimated 41% one-year survival rate and a median overall survival rate of 8.2 months.

“With the EU approval of nivolumab, patients in Europe have for the first time in more than 10 years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care,” said Emmanuel Blin, senior vice-president, head of commercialization, policy and operations at Bristol-Myers Squibb, said in a statement.

Meanwhile, a day prior to the drug’s approval in the EU, another trial testing Opdivo for the treatment of renal cell carcinoma was stopped early after it demonstrated superior efficacy to everolimus. Investigators involved with CheckMate -025, a Phase III trial, ended the comparative arm of the study because they determined Opdivo demonstrated a clear survival advantage.

Source: Bristol-Myers Squibb

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