Amgen announced new data from its PEAK and PRIME studies that support Vectibix (panitumumab), in combination with FOLFOX, as first-line therapy in patients with wild-type RAS metastatic colorectal cancer (mCRC)
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The Food and Drug Administration (FDA) has granted Fast Track designation to CRLX101 (Cerulean Pharma) in combination with Avastin (bevacizumab) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through two or three prior lines of therapy.
The FDA has granted Orphan Drug designation to marizomib (Triphase Accelerator) for the treatment of malignant glioma, an aggressive form of brain cancer with a significant unmet need due to its poor prognosis.
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.
Data from a Phase 1/2 study in patients with MDS who had disease progression on or after first-line azacitidine treatment showed initial signs of clinical activity with DSP-7888, and that it was well tolerated in study patients.
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.
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.
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 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 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).