(Corrects name to Bristol-Myers Squibb Co in headline and first paragraph)
NEW YORK, Jan 31 (Reuters) - Drugmaker Bristol-Myers Squibb Co said on Friday it was pulling the application to have its immunotherapies Opdivo and Yervoy approved in Europe as an initial treatment for advanced lung cancer, after regulators there balked at changes to the design of its clinical trials.
The drugmaker said it had no plans to refile the application in the European Union. Lung cancer is the most lucrative oncology market.
According to Bristol-Myers Squibb, Europe’s Committee for Medicinal Products for Human Use (CHMP) said it was not possible to assess the data from the company because of “multiple protocol changes” the company made in its trial.
The combination is still under review by the U.S. Food and Drug Administration (FDA), which granted the company priority review for the drugs as a treatment for first line non-small cell lung cancer earlier this month. The FDA is expected to decide on the treatment by May 15.
Opdivo is one of Bristol-Myers Squibb’s top-selling drugs, with analysts expecting $7 billion in sales for 2019. But the company’s sales of the drug has slowed in recent years as it has been eclipsed by Merck & Co’s rival drug Keytruda.
Keytruda is already approved to treat newly diagnosed advanced lung cancer in both the United States and Europe. Analysts estimate Merck’s 2019 sales of Keytruda were around $11 billion last year. (Reporting by Michael Erman; editing by Jonathan Oatis)