The sBLA was based on efficacy and safety data from the KEYNOTE-A18 trial.
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The Agency could not approve the BLA due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
The IMbrave050 study included 662 patients with HCC at high risk for recurrence after surgical resection or ablation with curative intent.
Tisotumab vedotin is an investigational antibody-drug conjugate targeted to tissue factor.
Genentech announced results from its Phase 3 study of Avastin (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) for the treatment of previously treated (recurrent), platinum-sensitive ovarian cancer.
Æterna Zentaris and Keryx Biopharmaceuticals announced agreement with the FDA regarding a Special Protocol Assessment on its Phase 3 trial for perifosine (KRX-0401) for the treatment of refractory metastatic colorectal cancer.
Roche announced the suspension of enrollment by the National Cancer Institute and US Eastern Cooperative Oncology Group (ECOG) for a Phase 3 study of Avastin (bevacizumab, from Roche and Genentech) in combination with chemotherapy in women with early-stage breast cancer.
Genentech announced that its Phase 3 study of Avastin (bevacizumab) plus chemotherapy following surgery in patients with early-stage colon cancer did not meet its primary endpoint of improvement in disease-free survival.