Licensing Agreement for Breast Cancer Drug Onzeald Signed by Nektar Therapeutics, Daiichi Sankyo Europe

Licensing Agreement for Breast Cancer Drug Onzeald Signed by Nektar Therapeutics, Daiichi Sankyo Europe
Nektar Therapeutics and Daiichi Sankyo Europe have announced they signed an agreement for Nektar’s investigational drug therapy Onzeald (etirinotecan pegol) — formerly NKTR-102 – just after the completion of a Phase 3 clinical trial in patients with advanced breast cancer. Breast cancer is the most frequently diagnosed cancer in women worldwide, with approximately 1.7 million new cases diagnosed in 2012 alone. There are nearly 250,000 newly diagnosed cases in the U.S. (and 470,000 in Europe) every year, and from 10 to 30 percent of patients with advanced breast cancer are also diagnosed with brain metastases. Onzeald is the first long-acting topoisomerase 1 inhibitor with an extended half-life and a unique structure that is engineered to concentrate the drug in tumors. In patients, the drug candidate leads to greatly prolonged plasma SN38 exposure, when compared to irinotecan, yet peak SN38 concentrations are at least five to 10 times less, which might lead to a favorable tolerability profile. The Phase 3 BEACON clinical trial was an open-label, randomized, multi-center study that enrolled 852 women with locally recurrent or metastatic breast cancer who had been previously treated with an anthracycline, taxane, and capecitabine therapies. Nektar will submit a Marketing Authorization Application (MAA) filing this month 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. The application follows the Committee for Medicinal Products for Human Use (CHMP) decision to grant an acceler
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