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news.The European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) for Bristol-Myers Squibb' nivolumab to treat non-small cell lung cancer (NSCLC).
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MAA for nivolumab is the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type.
Bristol-Myers Squibb senior vice-president and head of Oncology Development Michael Giordano said lung cancer is the leading cause of cancer death worldwide, and there remains a significant need for effective treatment options for patients with this disease.
"We are pleased to have two applications for nivolumab now under review in the E.U., and look forward to continued collaboration with health authorities around the world as we work to bring nivolumab to patients," Giordano said.
The MAA is based on data from the Phase II trial of nivolumab in third-line pre-treated squamous cell NSCLC (Study -063).
Apart from the MAA for lung cancer in the EU, the company has started a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.
Opdivo is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells.