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

… FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer On January 19, 2023, the … to tucatinib (Tukysa, Seagen Inc.) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or … 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 …

June 2022 Office of Women's Health e-Update

… Read FDA News Release FDA Grants Regular Approval to Fam-trastuzumab Deruxtecan-nxki for Breast Cancer On May 4, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) …

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 …

January-February 2020 Office of Women's Health e-Update

… granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with …