Therapy Areas: Respiratory
Bristol-Myers Squibb's Type II Variation Application for Opdivo plus Yervoy combination validated by European Medicines Agency
7 May 2018 -

Bristol-Myers Squibb Company (NYSE: BMY) a US-based pharmaceutical company, has announced that the European Medicines Agency (EMA) validated a type II variation application for the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for treatment in adult patients with first-line metastatic non-small cell lung cancer (NSCLC) who have tumour mutational burden (TMB) greater than or equal to 10 mutations/megabase (mut/Mb), it was reported on Friday.

Validation of the application confirms the submission is complete and begins the EMA's centralised review process.

Sabine Maier, MD, development lead, thoracic cancers, Bristol-Myers Squibb, commented, 'Europe has one of the highest incidence rates of advanced lung cancer, currently accounting for 20 percent of all cancer deaths. The Opdivo plus low-dose Yervoy combination has the potential to offer first-line NSCLC patients with TMB greater than or equal to 10 mut/Mb a chemotherapy-sparing I-O/I-O regimen. The validation of our application by the EMA is a step forward in the regulatory review process, and we will continue to work with urgency to bring precision immunotherapy to patients with lung cancer in the European Union.'

The application is based on data from Part 1 of CheckMate -227, a global Phase 3 study evaluating Opdivo-based regimens versus chemotherapy in patients with first-line advanced NSCLC across squamous and non-squamous histologies. Initial results from this study were presented at the American Association for Cancer Research Annual Meeting in April 2018 and simultaneously published in The New England Journal of Medicine.