Nektar Therapeutics announced that the company's oncology drug candidate, NKTR-102, has been granted orphan drug status for the treatment of women with ovarian cancer by the US Food and Drug Administration (FDA).
“This designation is an important step in the overall development program for NKTR-102 and underscores our commitment to treating women with ovarian cancer,” said Dr Lorianne Masuoka, senior vice president and chief medical officer of Nektar Therapeutics.
Nektar has a phase II study ongoing for NKTR-102 that is enrolling approximately 125 patients with platinum-resistant ovarian cancer whose disease has progressed following treatment with Pegylated Liposomal Doxorubicin (PLD) therapy. In addition, phase III planning is also underway for NKTR-102 in ovarian cancer.
NKTR-102 is an investigational agent and is not approved by the FDA, the European Medicines Agency (EMA) or other Health Authorities.
In the United States, the Orphan Drugs Act (ODA) provides for the orphan drug designation which aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country. The designation grants US market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a possible exemption from the FDA-user fee. The designation does not shorten the duration of the regulatory review and approval process.
Ovarian cancer is the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Approximately 22,000 new cases of ovarian cancer will be diagnosed and 14,000 deaths are expected to be caused by ovarian cancer in the United States this year. Treatment options following relapse are limited and overall long-term survival among ovarian cancer patients has not changed significantly in nearly 40 years.
Nektar is developing NKTR-102, a next-generation topoisomerase I inhibitor, with reduced peak concentrations and a continuous concentration profile. NKTR-102 was invented by Nektar using its advanced polymer conjugate technology platform, and is the first oncology product candidate to leverage Nektar's releasable polymer technology platform. It has been evaluated in two separate phase II studies for the treatment of platinum-refractory/resistant ovarian cancer and metastatic breast cancer patients. In addition, NKTR-102 is also being tested as a single agent in a phase II clinical trial in patients with second-line colorectal cancer and a phase I clinical trial evaluating NKTR-102 in combination with 5-FU therapy.
Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms.