Trodelvy: (Sacituzumab govitecan-hziy, DNA topoisomerase I inhibitor; Immunomedics)
- Immunomedics announced that the 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
- “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, SVP of Global Product Supply. “This approval enhances our ability to supply commercial product to the US 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”