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FDA Approves T-DXd in HR+, HER2-Low/Ultralow Breast Cancer
28 Jan 2025 00:55 GMT
… The FDA has approved trastuzumab deruxtecan for the treatment of … FASCO, professor, department of medicine, division of hematology/ … on the DESTINY-Breast04 trial (NCT03734029).3 Notably, … which consisted of capecitabine (Xeloda; 59.8%), nab-paclitaxel …
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Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment
24 Jan 2025 23:18 GMT
… U.S. Food and Drug Administration (FDA) is providing this communication … inform patients prior to treatment about the potential for … reactions.
Project Renewal
The FDA Oncology Center of Excellence, … as in Xeloda. The product labeling of both drugs state:
…
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Metronomic Capecitabine With an Aromatase Inhibitor Demonstrates Safety, Efficacy in Treatment of HR+, HER2– Metastatic Breast Cancer
15 Jan 2025 17:58 GMT
Metronomic capecitabine (Xeloda; Genetech) plus an … , controlled phase 3 MECCA trial (NCT02767661).1
Endocrine therapy … Docefrez; Sun Pharmaceutical Industries Europe B.V.) for treatment of MBC … al. US Food and Drug Administration approval overview in …
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ctDNA Positivity More Frequent Less Than 6 Months from Treatment in TNBC
20 Dec 2024 22:55 GMT
… the end of treatment.
The ZEST trial was considered the … ). Prior therapies included capecitabine (Xeloda; 61.1%; 31.8%), … the end of definitive treatment (EODT), 5.2% … ) pathological outcome from neoadjuvant treatment (non-pathologic complete response, …
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Biomarker-Guided Treatment Approaches Transform Lung and GI Cancer Management
13 Dec 2024 20:00 GMT
… and Medical Oncology, Mayo Clinic; co-leader, Advanced Clinical Trials … many treatment options, and there’s not a clinical trial … . However, only 2 drugs are FDA approved in the second … addition of zolbetuximab to capecitabine [Xeloda] and oxaliplatin [CAPOX] …
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Zolbetuximab Plus Chemotherapy Offers Survival Benefits in Treatment-Naive HER2– Gastric/GEJ Cancer
12 Nov 2024 20:15 GMT
… trials. These data were published in the New England Journal of Medicine … oral capecitabine (Xeloda) 1000 mg… trial that enrolled adult patients with CLDN18.2-positive, HER2-negative, treatment … fda.gov/drugs/;resources-information-approved-drugs/fda …
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Camber Pharmaceuticals Launches Generic Xeloda®
12 Nov 2024 16:21 GMT
Camber Pharmaceuticals is excited to announce the addition of Capecitabine Tablets, USP, to our product portfolio. Capecitabine is a nucleoside metabolic inhibitor indicated for the treatment of several cancers, including:
Colorectal Cancer
Breast Cancer
…
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Herceptin Combo Shows Limited Benefit in Gastric/GEJ Cancer
30 Jan 2025 22:02 GMT
… fluorouracil and oxaliplatin (FOLFOX); or Xeloda/oxaliplatin (CAPOX), the … reached across all 3 treatment arms in the overall … plus chemotherapy.
Before the trial amendment regarding the chemotherapy … of this phase 2 trial randomly assigned patients to …
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Zolbetuximab/Chemo Displays PFS, OS Benefits in Gastric Cancer Trials
25 Oct 2024 03:20 GMT
… Cancers, and chief medical officer of the … GLOW trial (NCT03653507), which evaluated capecitabine (Xeloda)-based … began by stating that both trials measured Claudin … FDA for treatment of advanced gastric and GEJ cancer. News release. Astellas Pharmaceuticals …
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FDA Approves Zolbetuximab in Advanced CLDN18.2+ Gastric/GEJ Adenocarcinoma
19 Oct 2024 03:16 GMT
… drug’s developer, Astellas Pharmaceuticals. … GLOW trial published in Nature Medicine … showed a median PFS benefit with zolbetuximab plus capecitabine (Xeloda … FDA for treatment of advanced gastric and GEJ cancer. News release. Astellas Pharmaceuticals …
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