Fam-Trastuzumab Deruxtecan-nxki - National Cancer Institute
Fam-trastuzumab deruxtecan-nxki is a type of targeted therapy drug called an antibody–drug conjugate. It is a monoclonal antibody that is chemically linked to a topoisomerase I-inhibiting drug called deruxtecan.
新一代ADC药物Enhertu（trastuzumab deruxtecan，DS-8201） …
Enhertu (fam-trastuzumab deruxtecan-nxki)是一种处方药，用于治疗 HER2阳性 患者。 不能通过手术切除的乳腺癌（不可切除）或已经扩散到身体其他部位的乳腺癌（转移性），之前接受过两次或以上的抗HER2乳腺癌治疗。
FDA grants accelerated approval to fam-trastuzumab deruxtecan …
On April 5, 2024, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or...
FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low …
On August 5, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or...
ENHERTU® (fam-trastuzumab deruxtecan-nxki) Patient Website
ENHERTU (en-HER-too) is a prescription medicine used to treat adults who have: Have breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer. Your disease has returned during or within 6 months of completing adjuvant chemotherapy (after surgery).
FDA approves fam-trastuzumab deruxtecan-nxki for …
On December 20, 2019, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (ENHERTU®, Daiichi Sankyo) for patients with unresectable or metastatic...
Fam-Trastuzumab Deruxtecan-Nxki for Unresectable or …
2024年4月5日 · The recommended fam-trastuzumab deruxtecan-nxki dosage for this indication is 5.4 mg/kg given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. This tumor agnostic indication is approved under accelerated approval based on objective response rate and duration of response.
US Food and Drug Administration Approval Summary: Fam-Trastuzumab …
2023年2月13日 · Fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd, ENHERTU) is an antibody-drug conjugate consisting of a humanized anti-HER2 monoclonal antibody covalently linked to a topoisomerase I inhibitor payload (an exatecan derivative) via a tetrapeptide-based cleavable linker.
ENHERTU® (fam-trastuzumab deruxtecan-nxki) | Official HCP Site
Locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab …
US Food and Drug Administration Approval Summary: Fam-Trastuzumab …
2023年4月10日 · Purpose: The US Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd) for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-low (immunohistochemistry 1 + or immunohistochemistry 2+/in situ hybridization-) breast cancer who have received a prior ...