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The FDA has granted NKTR-102 Orphan Drug status for the treatment of women with ovarian cancer.


The drug, a "next-generation topoisomerase I inhibitor with reduced peak concentrations and a continuous concentration profile, is made by Nektar Therapeutics and is now being studied in a Phase 2 trial that is enrolling 125 patients with platinum-resistant ovarian cancer whose disease has progressed following treatment with pegylated liposomal doxorubicin. Phase 3 planning is also under way, the company notes.


The Orphan Drugs Act aims to encourage the development of drugs in the diagnosis, prevention, or treatment of a medical condition affecting fewer than 200,000 people in the US and grants market exclusivity for a seven-year period if the sponsor complies with certain FDA specifications. The designation does not, though, shorten the duration of the regulatory review and approval process.


NKTR-102 is also being tested as a single agent in a Phase 2 clinical trial in patients with second-line colorectal cancer and a Phase 1 clinical trial evaluating NKTR-102 in combination with 5-FU.