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.
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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.
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.
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.
Lilly announced that the Phase 2 study of Cyramza (ramucirumab) in combination with docetaxel met its primary endpoint for patients with locally advanced or who failed prior platinum-based therapy.
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).
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.
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)
Regeneron announced results from an effectiveness study sponsored by the National Institutes of Health (NIH) in patients with diabetic macular edema (DME) treated with Eylea (aflibercept) Injection compared to Avastin (bevacizumab; Genentech) and Lucentis (ranibizumab; Genentech).
The FDA grants Genentech’s sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.