Compliance Management

BMS' Opdivo Injection Earns FDA Nod

Nov 13, 2016

Bristol-Myers Squibb Company announced that the U.S. FDA has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

According to the company, Opdivo is the first and only Immuno-Oncology treatment proven in a Phase 3 trial to significantly extend overall survival (OS) for these patients.

The approval was based on results from the Phase 3, CheckMate -141 trial in which Opdivo demonstrated statistically significant and clinically meaningful superior OS vs. the comparator arm, with a 30% reduction in the risk of death. The median OS was 7.5 months for Opdivo compared to 5.1 months for investigator’s choice.

“With this approval in head and neck cancer, we continue to lead the field in bringing our Immuno-Oncology science and the potential for increasing survival to more people with cancer,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb.

Squamous cell carcinoma of the head and neck (SCCHN) accounts for more than 90% of all head and neck cancers, and more than 50% of SCCHN patients present with Stage III or higher disease, which has higher potential for progression and recurrence. The relative five-year survival rate for metastatic head and neck cancers is <38%, and can be as low as 4% for recurrent or metastatic Stage IV disease.

Read the press release