The FDA has approved atezolizumab plus bevacizumab for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
9 Notwithstanding the uncertainty about benefits in the population aged 65 years or older, the Centers for Medicare & Medicaid Services (CMS) has covered bevacizumab therapy for its enrollees subsequent to FDA approval.10 Little is known about how clinicians have interpreted efficacy studies to ...
Although the clinical use of bevacizumab received an accelerated approval as a first-line agent in HER2-negative metastatic breast cancer to be used in combination with paclitaxel, later on, it was withdrawn by the FDA. The approval decision was supported by the results of the E2100 phase III...
Experts Comment on the GI/GU Cancer FDA Approvals From 2024 May 24th 2024 Oncology Experts Preview Top Abstracts From the 2024 ASCO Annual Meeting February 7th 2025 ATG-022 Demonstrates Safety, Preliminary Efficacy in Advanced CLDN18.2+ Gastric Cancer February 6th 2025 Case Closed: Experts ...
FDA drug approval summary: bevacizumab plus FOLFOX4 as second-line treatment of colorectal cancer. Oncologist. 2007;12(3):356–61. 3. Schutz FA, Je Y, Azzi GR, Nguyen PL, Choueiri TK. Bevacizumab increases the risk of arterial ischemia: a large study in cancer patients with a focus on ...
Food and Drug Administration (FDA) approved Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin for the treatment of six types of cancer. The FDA approval was based on a comprehensive analytical, non-clinical and clinical data package submitted to the FDA. The data demonstrated that Av...
FDA Drug Information Drug Description Indications Dosage Side Effects & Drug Interactions Warnings & Precautions Overdose & Contraindications Clinical Pharmacology Medication Guide WARNING GASTROINTESTINAL PERFORATIONS, SURGERY AND WOUND HEALING COMPLICATIONS, and HEMORRHAGE Gastrointestinal Perforations : The incidence...
Approval based on extrapolation was granted by the FDA for all other indications, including metastatic colorectal cancer (mCRC). The objective of this study was to evaluate the real-world effectiveness and safety outcomes of patients with mCRC initiated on bevacizumab-awwb versus bevacizumab in an...
“The recent FDA approval for atezolizumab in the metastatic setting is the first checkpoint inhibitor to be approved for ASPS. Actually, it's the first drug specifically to be approved for alveolar soft part sarcoma. It is also the first indication for atezolizumab in pediatrics. Because we we...
In May 2020, the FDA approved atezolizumab plus bevacizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy based on data from IMbrave150. More recently, in October 2020, the China National Medical Products Administration approved the com...