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...
ENHERTU is indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior...
ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by...
FDA Approves Enhertu for HER2-Low and -Ultralow Breast Cancer
3 days ago · A patient’s HER2 status would be determined by an FDA-approved test, as noted in a press release from Daiichi Sankyo and AstraZeneca, the manufacturers of Enhertu. The approval of Enhertu, an antibody drug conjugate, was based on findings from the DESTINY-Breast06 trial presented in June 2024. In this trial, treatment with Enhertu resulted in ...
Enhertu Approved for Any HER2-Positive Solid Cancer
May 3, 2024 · The drug trastuzumab deruxtecan (Enhertu) can now be used to treat a wide variety of cancers, thanks to a new approval from the Food and Drug Administration (FDA).
Enhertu approved in the US as first HER2-directed therapy for …
3 days ago · Enhertu (5.4 mg/kg) is approved in the US for adult patients with unresectable or metastatic HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting based on the results ...
FDA D.I.S.C.O. Burst: Enhertu
On April 5, 2024, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with unresectable or metastatic HER2-positive solid tumors...
FDA D.I.S.C.O. Burst: Enhertu
On May 4, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a...
ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the …
4 days ago · ENHERTU (5.4 mg/kg) is approved in the US for adult patients with unresectable or metastatic hormone receptor HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting based ...
ENHERTU® Approved in the U.S. as First HER2 Directed Therapy …
4 days ago · ENHERTU (5.4 mg/kg) is approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the ...
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