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The FDA grants Genentech’s sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.

Genentech announced that the Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.

Genentech announced positive results from its Phase 3 study of Avastin (bevacizumab) plus radiation and temozolomide (Temodar; Merck & Co., Inc.) chemotherapy in patients with newly diagnosed glioblastoma.

The conversion from provisional to full approval was based on totality of evidence of Avastin in glioblastoma.

The use of Prophage Series G-100 (HSPPC-96; Agenus) in combination with current standard of care (radiation and temozolomide) demonstrates improvement in progression free survival in patients with newly diagnosed glioblastoma multiforme (GBM).

The FDA has confirmed that a counterfeit version of Roche’s Altuzan 400mg/16mL (bevacizumab), an injectable cancer medication, found in the US contains no active ingredient.

Genentech announced that the FDA has expanded the use of Avastin (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy as second-line treatment for patients with metastatic colorectal cancer (mCRC) whose cancer has progressed on a first-line Avastin-containing regimen.

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.

Study patients who received Avastin plus chemotherapy followed by Avastin alone, had a greater median PFS vs patients who received chemotherapy alone (18.2 months vs 12 months; hazard ratio [HR] 0.62, 95% CI, 0.52-0.75; P<.0001).

Genentech, a member of the Roche Group, announced results from the Phase 3 AVAglio study; the study evaluated Avastin (bevacizumab) in combination with radiation and temozolomide (Temodar; Merck) chemotherapy in patients with newly diagnosed glioblastoma.