Tag Archives: Daiichi Sankyo

Aug. 23, 2022–Guardant Health announced that the FDA has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic to select patients with unresectable or metastatic HER2 (ERBB2)-mutant non-small cell lung cancer whose tumors have activating HER2 mutations (single nucleotide variants and exon 20 insertions) for treatment with Enhertu

May 18, 2022—Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the United States for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

February 2020—The FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2–directed antibody and topoisomerase inhibitor conjugate.