Nivolumab Lung Cancer Drug EMA Validation for Marketing Authorization Application

Nivolumab Lung Cancer Drug EMA Validation for Marketing Authorization Application

shutterstock_152704451The first immune-checkpoint targeting drug for non-small cell lung cancer (NSCLC), Opdivo (nivolumab), was just validated by the European Medicines Agency (EMA) to review its Marketing Authorization Application (MAA), according to a press release by the Bristol-Myers Squibb Company.

The MAA resulted from data obtained from Opdivo’s Phase 2 trial in third-line pre-treated squamous-cell NSCLC.

According to the World Health Organization, lung cancer is the worldwide leading cause of cancer, with a death toll of 1.5 million deaths per year. NSCLC is a type of epithelial lung cancer characterized by its insensitivity to chemotherapy and radiation therapy.

Nivolumab inhibits tumor mediated blocking of human PD-1 (programmed death-1) receptor in T cells, thus preventing the tumor from impairing an immune mediated response.

Back in 2013, the FDA granted a Fast Track designation for Opdivo in multiple cancer types, including NSCLC, melanoma, and renal cell carcinoma (RCC). In May 2014, it expanded Opdivo’s application and granted its first Breakthrough Therapy Designation to patients with Hodgkin’s lymphoma that had failed previous treatments (stem-cell transplant, cell transplant and brentuximab). The MAA for Opdivo in the treatment of advanced melanoma is currently under evaluation in the European Union.

Opdivo manufacturing and marketing were already approved in Japan for the treatment of patients with unresectable melanoma, making it the first and only PD-1 immune checkpoint inhibitor approved globally.

Michael Giordano, senior vice president, head of Oncology Development, Bristol-Myers Squibb, commented in the company’s press release, “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.”

The company is currently developing global worldwide programs to investigate Opdivo in multiple cancer types, such as head and neck cancer, glioblastoma and non-Hodgkin lymphoma, alongside NSCLC, melanoma and renal cell carcinoma (RCC).

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