Daiichi Sankyo to market investigational drug therapy, Onzeald (etirinotecan pegol, NKTR-102) in Europe, Turkey and Switzerland.- Nektar Therapeutics.
Nektar Therapeutics has entered into an agreement with Daiichi Sankyo Europe for Nektar's investigational drug therapy, Onzeald (etirinotecan pegol, NKTR-102), which has completed a Phase III clinical trial (the BEACON study) in patients with advanced breast cancer. The agreement grants Daiichi Sankyo Europe exclusive rights to market Onzeald in Europe (EEA), Switzerland and Turkey. Nektar Therapeutics will retain rights to Onzeald in the United States and the rest of the world. Nektar plans to submit an MAA filing in June 2016 seeking conditional approval from the European Medicines Agency (EMA) for the use of Onzeald in the treatment of patients with advanced breast cancer and brain metastases.
On May 26, 2016, the Committee for Medicinal Products for Human Use (CHMP) granted an accelerated assessment procedure for the planned Onzeald filing, which provides for an accelerated MAA review timeline.
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