Bristol-Myers Squibb’s new lung cancer drug accepted for EU review

Bristol-Myers Squibb has announced that the European Medicines Agency (EMA) has accepted its drug nivolumab for review as a treatment for non-small cell lung cancer.

The marketing authorisation application for the therapy has been validated, marking the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumour type.

Data from a phase II trial has demonstrated the potential efficacy of the drug in this indication, with these results supporting the company's regulatory application. There remains a strong need for new lung cancer therapies, as the disease is the leading cause of cancer death worldwide.

The drug is also being assessed by the EMA as a treatment for advanced melanoma.

Dr Michael Giordano, senior vice-president and head of oncology development at Bristol-Myers Squibb, said: "We are pleased to have two applications for nivolumab now under review in the EU, and look forward to continued collaboration with health authorities around the world as we work to bring nivolumab to patients."

The company reported positive phase III trial data last week showing the drug's efficacy as a melanoma therapy. It has been granted an accelerated assessment by the EMA's Committee for Medicinal Products for Human Use in this indication.