The European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on Nektar Therapeutics’application for orphan medicinal product status for the company’s lead oncology candidate, NKTR-102, for the treatment of women with ovarian cancer.
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.[1] In the European Union, there are approximately 44,000 newly diagnosed cases of ovarian cancer each year and approximately 29,000 deaths result from ovarian cancer each year. [2] In the U.S., approximately 22,000 new cases of ovarian cancer will be diagnosed and 14,000 deaths are expected to be caused by ovarian cancer this year.[1] Treatment options following relapse are limited and overall long-term survival among ovarian cancer patients has not changed significantly in nearly 40 years.[3]
Orphan medicinal product designation
In the European Union, orphan medicinal product designation is designed to encourage the development of medicinal products for the diagnosis, treatment or prevention of life-threatening or very serious conditions that are rare and affect not more than 5 in 10,000 persons in the European Union (EU). The designation provides incentives for sponsors to develop orphan medicinal products, including market exclusivity to a drug for a particular indication for a ten-year period after the drug is granted marketing approval. Additional incentives for the sponsor may include protocol assistance, filing fee reductions, and research grants.
Significant unmet needs
“There is a significant unmet need for additional treatments to address ovarian cancer,” said Carlo DiFonzo, PhD, Vice President of Drug Development and Regulatory Affairs for Nektar. “We are pleased to have received a positive opinion from COMP for orphan medicinal product status in Europe to augment the U.S. Orphan Drug Designation recently received in April, as we continue the treatment of patients in our Phase II study of NKTR-102 in women with platinum-resistant ovarian cancer.”
Nektar has a multi-national 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.
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. NKTR-102 has been evaluated in two separate Phase II studies for the treatment of platinum-refractory/resistant ovarian cancer and for the treatment of second- and third-line 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.
For more information:
Clinical trials for NKTR-102
[1] American Cancer Society, 2011.
[2] International Journal of Cancer
[3] Ovarian Cancer National Alliance
