FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

… 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients … (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Efficacy was evaluated in a …

FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer

… May 4, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult … 6 months of completing therapy. In December 2019, fam-trastuzumab deruxtecan-nxki received accelerated approval for …

FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)

… drug approvals. On January 15, 2021, FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with … gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen. Efficacy was evaluated in a …

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

… 5, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult … Center for Drug Evaluation and Research … FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low breast cancer … FDA …

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

… Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult … and Research … FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell …

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

… cancer drug approval. On May 4, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with … 6 months of completing therapy. In December 2019, fam-trastuzumab deruxtecan-nxki received accelerated approval for …

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

… Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult … disease and embryo-fetal toxicity. The recommended fam-trastuzumab deruxtecan-nxki dosage for this indication is 5.4 …

FDA D.I.S.C.O. Burst Edition: FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-positive solid tumors

… April 5, 2024, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with … of the April 5, 2024, FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic …

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

… drug approvals. On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with … a soundcast of the 8/5/2022 FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki) for patients unresectable or …

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.)

… Transcript FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki) FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic …

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 …

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 (Cancer)/Hematologic Malignancies Approval Notifications

… test. 4/18/2024 FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive … Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) …

Ongoing | Cancer Accelerated Approvals

… PFS analyses in the interim report. 4/30/2032 Enhertu (fam-trastuzumab deruxtecan-nxki) Adult patients with unresectable or … 12/31/2026 Tukysa (tucatinib) In combination with trastuzumab for the treatment of adult patients with RAS …

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 …

FDA Roundup: April 9, 2024

… On Friday, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult …

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 …

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 …