Immunomedics (IMMU) Announces FDA Orphan Drug Designation of Trodelvy for Adult and Pediatric Glioblastoma

Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Trodelvy (sacituzumab govitecan-hziy) orphan status for the treatment of adult and pediatric patients with glioblastoma.

“Glioblastoma is an aggressive cancer with a large unmet need. This orphan drug designation is an important milestone for Immunomedics as we strive to broaden the clinical utility of Trodelvy,” said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. “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. We look forward to continuing our evaluation of Trodelvy’s potential to improve the prognosis for this underserved patient population.”

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 U.S. 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.

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