Immunomedics announced that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted Trodelvy (sacituzumab govitecan-hziy) orphan status for the treatment of adult and paediatric patients with glioblastoma.
“This orphan drug designation is an important milestone for Immunomedics as we strive to broaden the clinical utility of Trodelvy. As reported at the recent ESMO Congress, Trodelvy has shown encouraging activity in an early-stage study in brain cancers, including partial responses in small cohorts of patients with brain metastasis from breast cancer and recurrent glioblastoma,” said Dr Loretta M Itri, Chief Medical Officer of Immunomedics
Orphan drug status is granted by the FDA to support development of drugs and biologics for underserved patient populations, or rare disorders that affect fewer than 200,000 people in the US. The orphan drug designation qualifies the company for various development incentives, including tax credits for qualified clinical studies, a waiver of the new drug application fee, and a designated period of market exclusivity following approval.