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.
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The FDA has announced that it is recommending the removal of the breast cancer indication from the label for Avastin (bevacizumab, from Genentech) because the drug has not been shown to be safe and effective for that use.
Genentech announced that the FDA has extended the review period for the supplemental Biologics License Applications (sBLAs) for Avastin (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer by an additional 90 days.
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 has received FDA approval for Avastin (bevacizumab) plus interferon-alfa for treatment of metastatic renal cell carcinoma.
The FDA has granted accelerated approval of Avastin (bevacizumab, from Genentech) for patients with glioblastoma with progressive disease following prior therapy.
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.
Genentech is warning healthcare providers of 36 reports of intraocular adverse events following the off-label intravitreal use of Avastin (bevacizumab) injection.
Genentech has received reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin (bevacizumab) in combination with Sutent (sunitinib malate, from Pfizer).