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Showing 251 - 256FDA Approves Denosumab to Treat Giant Cell Tumor of the Bone
The U.S. Food and Drug Administration (FDA) today expanded the approved use of denosumab (Xgeva) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually noncancerous tumor. Denosumab, which was granted orphan product designation, was reviewed under the FDA’s ...
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The U.S. Food and Drug Administration today approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma, the most dangerous type of skin cancer. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors...
FDA Approves Regorafenib for Advanced Gastrointestinal Stromal Tumors
The FDA has expanded the approved use of regorafenib (Stivarga) to treat patients with metastatic or unresectable gastrointestinal stromal tumors (GIST) that no longer respond to treatment with imatinib (Gleevec) or sunitinib (Sutent). Regorafenib, a multikinase inhibitor, blocks several enzymes...
FDA Approves New Treatment for HER2-positive, Metastatic Breast Cancer
The FDA approved ado-trastuzumab emtansine (Kadcyla), referred to as T-DM1 during clinical research, for patients with HER2-positive, metastatic breast cancer who were previously treated with trastuzumab (Herceptin) and taxane chemotherapy. “[Ado-trastuzumab emtansine] is trastuzumab...
FDA Approves Pomalidomide for Advanced Multiple Myeloma
The FDA approved pomalidomide (Pomalyst) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide, an oral immunomodulatory agent, is intended for patients who have received at least two prior therapies, including lenalidomide...
Imatinib Receives New Indication for Children with Acute Lymphoblastic Leukemia
The FDA approved a new use of imatinib (Gleevec) to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated....
