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Immunomedics announced FDA approval of Samsung Biologics as antibody manufacturer of Trodelvy
17 Aug 2020
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”
Samsung Biologics to manufacture Trodelvy’s antibody at commercial level
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Our outlook:
- In 2020, Immunomedics has started using hRS7 antibody, produced by Samsung Biologics, for the clinical trials
- This approval for Samsung Biologics to manufacture “hRS7 antibody” on a commercial scale will ensure long-term supply of the product in the US market. Immunomedics is also looking for a means to make Trodelvy available widely
– Dr. Kowndinya, CI Scientists
Background:
- Trodelvy 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. It is the first ADC the FDA has approved for the treatment of patients with metastatic triple-negative breast cancer
- Immunomedics proprietary ADC platform centers on using a novel linker that does not require an enzyme to release the payload to deliver an active drug inside the tumor cell and the tumor microenvironment, thereby producing a bystander effect
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