Opdivo to go before EU, US regulators in head and neck cancer
pharmafile | July 19, 2016 | News story | Manufacturing and Production, Research and Development | EMA, EU, FDA, US, head and neck cancer, opdivo
Bristol-Myers Squibb has announced that its lead oncology drug, Opdivo (nivolumab), is set to go before regulators in the US and the EU who will decide whether or not to approve the treatment in patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck.
Hailed as a wonder drug, BMS has continued to trial Opdivo in numerous cancer indications following approval in the likes of melanoma, non-small cell lung cancer and renal cell carcinoma.
In April, Opdivo was granted priority review for head and neck cancer from the US Food and Drug Administration (FDA). The US regulator has a project action date of November 11. The European Medicines Agency (EMA) has validated a type II variation application for the same patient population. Validation of the application confirms the submission is complete and initiates the next step of the EMA’s centralised review process.
These regulatory submissions are based on the Phase III CheckMate-141 trial, where Opdivo showed the biggest increase in survival for patients with head and neck cancer for 20 years.
Jean Viallet, global clinical research lead in oncology at BMS, says: “Squamous cell carcinoma of the head and neck that progresses after platinum therapy is a devastating disease with a poor prognosis and has had very few treatment advancements in nearly a decade.
“Based on findings from CheckMate-141, Opdivo is the first and only PD-1 inhibitor to show an overall survival benefit in a Phase III trial in these patients. These milestones are important steps in the regulatory processes, and we look forward to working with authorities in the US and Europe to offer Opdivo to this patient population.”
Sean Murray
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