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FDA grants orphan drug status to ovarian cancer treatment
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The FDA granted orphan drug designation to liposomal encapsulated paclitaxel, or LEP-ETU, an ovarian cancer treatment in development by Insys Therapeutics Inc., the company announced today.
“We are pleased to have received orphan drug designation for LEP-ETU to treat ovarian cancer, a devastating and difficult-to-treat disease,” Michael L. Babich, president and CEO of Insys Therapeutics, said in a press release. “By entrapping the paclitaxel with liposomes, we believe our LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy of the cancer-fighting paclitaxel. We are currently evaluating next steps with respect to this drug product candidate.”
Ovarian cancer is the leading cause of death from gynecologic cancers in the United States and is the fifth leading cause of cancer death among American women.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.