Date: 15-Oct-2020

US FDA Grants Orphan Drug Status To Immunomedics’ Trodelvy To Treat Glioblastoma

Immunomedics, a leading biopharmaceutical company, 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 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 US 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.

Trodelvy (sacituzumab govitecan-hziy) is the lead product and the most advanced program in Immunomedics’ unique antibody-drug conjugate (ADC) platform. Trodelvy is an ADC that is directed against Trop-2, a cell-surface protein expressed in many solid cancers. Trodelvy binds to Trop-2 and delivers the anti-cancer drug, SN-38, to kill cancer cells. Immunomedics has an extensive development program for Trodelvy, including multiple ongoing studies in triple-negative breast cancer, metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents.

According to the National Cancer Institute (NCI), an estimated 23,890 American will be diagnosed with brain and other nervous system cancer in 2020 and about 18,020 people will die from the disease in the US this year. Among the numerous brain tumor types, glioblastoma (GBM) is the most aggressive, with median progression-free survival (PFS) and median overall survival (OS) from diagnosis of 6.2-7.5 months and 14.6-16.7 months, respectively, having been reported in clinical trials. For patients with recurrent GBM, chemotherapy regimens are associated with overall response rates of 4-9%, 6-month PFS of 10-19%, and median OS of 5-10 months