The Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Insys Therapeutics’ Liposomal Encapsulated Paclitaxel (LEP) for the treatment of ovarian cancer.
Ovarian cancer is a devastating and difficult-to-treat disease with limited treatment options.
LEP works by entrapping the paclitaxel with liposomes. “We believe our LEP-ETU formational could potentially have reduced toxicity, while maintaining or enhancing efficacy of the cancer-fighting paclitaxel,” said Michael L. Babich, president and chief executive officer for Insys Therapeutics. “We are currently evaluating next steps with respect to this drug product candidate.”
Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval, as well as certain financial incentives that help support the drug’s development.
Ovarian cancer is the leading cause of death from gynecologic cancers in the United States. In 2014, there were an estimated 21,980 new cases diagnosed and an estimated 14,270 deaths from ovarian cancer in the United States.
What causes the disease is hard to determine but factors that increase a woman’s risk of developing ovarian cancer include advanced age, obesity, family history, exposure to fertility drugs, long-term use of estrogen (without progesterone), a history of certain medical conditions, smoking and alcohol use, and high-fat diets.
Another risk factor is the use of talcum powder applied to the genital area or on sanitary napkins. Talc can travel through the uterus, through the fallopian tubes, and into the ovaries where it can inflame tissue and invite cancerous tumor growth.
Source: Insys Therapeutics