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FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas
… ces-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas … On … 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients …
FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer
… -information-approved-drugs/fda-grants-regular-approval-fam-trastuzumab-deruxtecan-nxki-breast-cancer … On May 4, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) …
FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)
… roved-drugs/fda-disco-burst-edition-enhertu-fam-trastuzumab-deruxtecan-nxki-and-combination-opdivo-nivolumab-and … … drug approvals. On January 15, 2021, FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with …
FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive breast cancer
… Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (ENHERTU®, Daiichi Sankyo) for patients with … or more prior anti-HER2 therapies. Patients received fam-trastuzumab deruxtecan-nxki 5.4 mg/kg by intravenous infusion …
FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low breast cancer
… drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-low-breast-cancer … On August 5, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) …
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer
… ormation-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung … On August … Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) …
FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancer
… oved-drugs/fda-disco-burst-edition-fda-approval-enhertu-fam-trastuzumab-deruxtecan-nxki-adult-patients … Podcast Welcome back to the … cancer drug approval. On May 4, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult …
FDA D.I.S.C.O. Burst Edition: FDA approvals of Tabrecta (capmatinib) for metastatic non-small cell lung cancer and Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-mutant non-small cell lung cancer
… 11, 2022, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with … metastatic non-small cell lung cancer, and Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic …
FDA D.I.S.C.O. Burst Edition: FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer, and Nubeqa (darolutamide) in combination with docetaxel for metastatic hormone-sensitive prostate cancer
… ved-drugs/fda-disco-burst-edition-fda-approvals-enhertu-fam-trastuzumab-deruxtecan-nxki-unresectable-or … Podcast Welcome back to the … drug approvals. On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult …
FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
… granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with … breast cancer since the introduction of Herceptin (trastuzumab) in 1998. The approval of Enhertu represents the …
La FDA aprueba la primera terapia dirigida para el cáncer de mama bajo en HER2
… UU. (FDA, por sus siglas en inglés) aprobó Enhertu (fam-trastuzumab-deruxtecan-nxki), una infusión intravenosa para el … … Office of the Commissioner … La FDA aprobó Enhertu (fam-trastuzumab-deruxtecan-nxki), una infusión intravenosa para …
Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
… (zanubrutinib) FDA approvals of Tukysa (tucatinib) with trastuzumab for colorectal cancer and Brukinsa (zanubrutinib) … Burst Edition: Tabrecta (capmatinib) and Enhertu (fam-trastuzumab deruxtecan-nxki) FDA approvals of Tabrecta (capmatinib) for …
Oncomine™ Dx Target Test – P160045/S035
… from treatment with an FDA-approved drug, ENHERTU (fam-trastuzumab deruxtecan-nxki). In normal tissue, the ERBB2 proteins … if the patient is eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki). The report is sent to the …
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
… (Leica Biosystems) Breast Cancer - Tissue Herceptin (trastuzumab) BLA 103792 ERBB2 (HER2) HER-2 protein … Medicine, Inc.) Breast Cancer - Tissue Herceptin (trastuzumab) BLA 103792 ERBB2 ( HER2 ) ERBB2 ( HER2 ) … Cell Lung Cancer (NSCLC) - Plasma ENHERTU (fam-trastuzumab deruxtecan-nxki) BLA 761139 ERBB2 ERBB2 Activating Mutations …
Oncology (Cancer) / Hematologic Malignancies Approval Notifications
… indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing … FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer On January 19, 2023, the … FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer On …
Guardant360 CDx – P200010/S008
… may benefit from personalized treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki). How does it work? A patient’s blood … who may be eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki) based on the test results. The …
Oncology Regulatory Review
… solid tumors. Other notable approvals included: Fam-trastuzumab deruxtecan-nxki, for unresectable or metastatic HER2-low … 1, 3 (alpelisib) PROS 81 Y Y 5/4/2022 Enhertu 2 (fam-trastuzumab) unresectable or met HER2+ BC 62 Y Y 5/27/2022 …
Ongoing | Cancer Accelerated Approvals
… 12/31/2026 Tukysa (tucatinib) In combination with trastuzumab for the treatment of adult patients with RAS … The trial should compare tucatinib in combination with trastuzumab with the standard of care in patients with RAS … for all patients. 12/31/2025 Enhertu (Fam-trastuzumab deruxtecan-nxki) Adult patients with unresectable or …
FDA Roundup: August 12, 2022
… On Thursday, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with …
Table of Pharmacogenomic Biomarkers in Drug Labeling
… Reactions, Clinical Pharmacology, Clinical Studies Ado-Trastuzumab Emtansine Oncology ERBB2 (HER2) Indications and … Usage, Dosage and Administration, Clinical Studies Fam-Trastuzumab Deruxtecan-nxki (1) Oncology ERBB2 (HER2) Indications and …
Verified Clinical Benefit | Cancer Accelerated Approvals
… least 2 prior regimens 12/28/2004 7/18/2022 Enhertu (Fam-trastuzumab deruxtecan-nxki) Adult patients with unresectable or … 11/20/2015 Perjeta (pertuzumab) In combination with trastuzumab and docetaxel for neoadjuvant treatment of …
New Drug Therapy Approvals 2019
… of larvae in contaminated water or food. Enhertu (fam-trastuzumab deruxtecan-nxki) injection, approved under FDA’s accelerated … post-thrombotic syndrome (damage to vein). Kadcyla (ado-trastuzumab emtansine) injection, originally approved in 2013 …
Novel Drug Approvals for 2019
… adults Press Release Drug Trials Snapshot 47. Enhertu fam-trastuzumab deruxtecan-nxki 12/20/2019 To treat metastatic breast cancer …
Oncology Regulatory Review
… Name(s) Indication AAid/RTOR 1. 1/15/2021 Enhertu 5 (fam-trastuzumab deruxtecan-nxki) GEJ Y/N 2. 1/15/2021 Darzalex Faspro 1 …
Drug Trials Snapshot: ENHERTU
… Package Insert for complete information. ENHERTU (fam-trastuzumab deruxtecan-nxki) (en HER too) Daiichi Sankyo, Inc. Approval …