Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on Nektar Therapeutics' application for orphan medicinal product status for ovarian cancer drug NKTR-102.
Subscribe to our email newsletter
Currently, the company is recruiting around 125 patients in a multi-national ongoing Phase 2 study of NKTR-102 in patients with platinum-resistant ovarian cancer whose disease has progressed after treatment with pegylated liposomal doxorubicin (PLD) therapy.
Nektar plans to initiate a Phase 3 trial of NKTR-102 in patients with ovarian cancer soon.
Nektar Drug Development and Regulatory Affairs vice president Carlo DiFonzo said they are pleased to have received a positive opinion from COMP for orphan medicinal product status in Europe to augment the US Orphan Drug Designation recently received in April, as they continue the treatment of patients in their Phase 2 study of NKTR-102 in women with platinum-resistant ovarian cancer.