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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Amgen and Allergan announced that their biosimilar candidate ABP 215 met its primary and secondary endpoints in a Phase 3 study evaluating its efficacy and safety compared with Avastin (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).
Bevacizumab extended survival in women with relapsed/advanced cervical cancer, the first time a targeted agent has significantly improved OS in gynecologic cancer, according to data presented at ASCO 2013.
Carboplatin plus first-line combination pemetrexed and bevacizumab therapy exhibits efficacy among elderly patients diagnosed with nonsquamous NSCLC, found data presented at ASCO 2013.
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.
Mirvetuximab soravtansine is an antibody-drug conjugate comprised of a FRα-binding antibody, a cleavable linker, and a potent tubulin-targeting agent.
Tisotumab vedotin is an investigational antibody-drug conjugate targeted to tissue factor.
Mirvetuximuab soravtansine uses a humanized FRα-binding antibody to target antibody-drug conjugates specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.
REACH-2 was a randomized, double-blind, placebo-controlled trial that enrolled 292 patients with hepatocellular carcinoma (HCC) who were intolerant to, or had disease progression while on or following treatment with sorafenib and had a high alpha-fetoprotein (AFP-High) defined as AFP ≥400ng/mL.