Trodelvy Shows Superiority to Chemo for Advanced TNBC in Phase 3 Trial

Trodelvy Shows Superiority to Chemo for Advanced TNBC in Phase 3 Trial
Trodelvy (sacituzumab govitecan), compared with standard chemotherapy, significantly prolonged overall survival and improved the overall response rate of patients with metastatic triple-negative breast cancer (mTNBC) who had at least two prior lines of therapy, a Phase 3 trial reported. Based on these findings, recently presented as a late-breaking abstract at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, the therapy’s developer, Immunomedics, intends to file a request for Trodelvy's full approval for this patient group by year's end. “We believe these remarkable results should facilitate the establishment of Trodelvy as a new standard of care in patients with third-line mTNBC,” Loretta M. Itri, the company's chief medical officer, said in a press release. Immunomedics will submit a supplemental application to the U.S. Food and Drug Administration (FDA) with these confirmatory trial data to support Trodelvy's full approval, Itri said. The company is also planning to file a request with the European Medicines Agency early next year to possibly "make this important new treatment available to mTNBC patients in Europe.” Trodelvy is an antibody-drug conjugate, made up of an antibody targeting TROP-2 — a protein found in different types of solid tumors, including more than 90% of those in TNBC patients — that is linked to the toxic compound  SN-38. Once the antibody binds to cancer cells that contain the TROP-2 protein on their surface, SN-38 is released, destroying the cells. The FDA approved Trodelvy in April — under its accelerated approval program — as a third-line treatment for patients with mTNBC based on data from the Phase 1/2 IMMU-132 trial (NCT01631552). Study findings showed Trodelvy was able to reduce t
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