Bristol-Myers slumps as EU and USA delay lung cancer filings

23 October 2018

Shares in Bristol-Myers Squibb (NYSE: BMY) fell 6% on Monday, after the firm made public regulatory setbacks in the USA and Europe related to its Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination therapy.

The firm has submitted applications to broaden the label to include first-line treatment for certain non-small cell lung cancer patients, based on data from Part 1 of the ongoing Phase III CheckMate -227 trial.

Bristol-Myers says the European Medicines Agency (EMA) has now requested additional information from the trial, including an overall survival (OS) analysis for certain patients.

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