On August 17, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that the U.S. Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for Samsung Biologics to produce commercial-scale hRS7, the antibody used in Trodelvy (sacituzumab govitecan-hziy), at its manufacturing facilities in Incheon, South Korea (Press release, Immunomedics, AUG 17, 2020, View Source [SID1234563743]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We want to thank the FDA for working collaboratively with us in expediting this PAS approval in the midst of the COVID-19 pandemic," said John Stubenrauch, Senior Vice President of Global Product Supply. "This approval enhances our ability to supply commercial product to the U.S. market, where the unmet need across our lead indications is very high. We have been using drug product that were produced with antibody manufactured by Samsung in clinical trials in the U.S. over the course of 2020, and we now look forward to further scaling our commercial supply of Trodelvy globally."
Trodelvy is the first ADC the FDA has approved for the treatment of people with metastatic triple-negative breast cancer. It contains the hRS7 antibody that binds to Trop-2, a cell-surface protein expressed in many solid cancers, and helps Trodelvy deliver the anti-cancer drug, SN-38, to kill the cancer cells.
"The Samsung partnership highlights our overall strategy to scale our supply chain and help ensure we can meet our commitments to patients globally as we seek to broaden the availability of Trodelvy geographically and across tumor types," commented Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics.