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.
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The sBLA was based on efficacy and safety data from the KEYNOTE-A18 trial.
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.