Bristol-Myers Squibb’s new investigational drug Opdivo, or nivolumab, already under review in the U.S. and E.U. for the treatment of advanced melanoma, is now being reviewed in the EU for the treatment of non-small cell lung cancer (NSCLC) as well.
Opdivo is a fully human PD-1 immune checkpoint inhibitor that targets the PD-1 receptor on the surface of activated T cells, avoiding suppression of efficient anti-tumoral immune responses.
Bristol-Myers Squibb is currently developing a global program to study Opdivo in different types of tumors either as a monotherapy or in combination with other drugs, in more than 35 trials enrolling around 7,000 patients worldwide.
This experimental therapy had already received a breakthrough therapy designation as a treatment for patients with previously treated melanoma and patients with Hodgkin lymphoma. Furthermore, along with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) also granted an accelerated assessment to the medication.
“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,” Michael Giordano, M.D., senior vice president, Head of Oncology Development, Bristol-Myers Squibb said in a company’s press release. “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.”
The Marketing Authorization Application submitted to the EMA in lung cancer is based on promising data from a Phase 2 study of nivolumab in third-line pre-treated squamous cell NSCLC.
Furthermore, the company has already announced it began a submission with the FDA for Opdivo in the treatment of the same population of lung cancer patients.