FDA Updates

The US Food and Drug Administration (FDA) today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS)—liposarcoma and leiomyosarcoma—that cannot be removed by surgery (unresectable) or is advanced (metastatic).
The US Food and Drug Administration (FDA) granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non–small-cell lung cancer (NSCLC) whose disease has progressed after other treatments, and with tumors that express a protein called PD-L1.
On September 30, 2015, the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.
  • Dinutuximab FDA-Approved for Pediatric Patients with High-Risk Neuroblastoma
  • First HDAC Inhibitor, Panobinostat, Approved for Patients with Multiple Myeloma
  • Palbociclib Approved for Metastatic Breast Cancer in Postmenopausal Women
  • FDA Expedites Approval of Lenvatinib for Refractory Differentiated Thyroid Cancer
  • Nivolumab First Immunotherapy to Get FDA Approval for Metastatic Lung Cancer
  • Lenalidomide Combined with Dexamethasone Receives Expanded Indication for Patients with Newly Diagnosed Myeloma
Bevacizumab (Avastin; Genentech) received FDA approval on January 23, 2013, for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy for treating patients with metastatic colorectal cancer (mCRC) with disease that has progressed on a regimen containing first-line bevacizumab.
The US Food and Drug Administration (FDA) approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE) for the treatment of patients with ovarian cancer with disease progression after platinum-based chemotherapy and for the treatment of AIDS-related sarcoma in patients after failure of systemic chemotherapy or intolerance to that therapy. Approval for doxorubicin hydrochloride liposome injection was granted on February 4, 2013.
The FDA expanded the labeling of pemetrexed (Alimta, Eli Lilly and Company) to include the results of an additional trial evaluating its safety and efficacy for the initial treatment of patients with locally advanced or metastatic, nonsquamous, non‒small cell lung cancer followed by pemetrexed maintenance in patients with disease that has not progressed after 4 cycles of platinum and pemetrexed as first-line chemotherapy. The approval for expanded labeling was granted on October 17, 2012.
The US Food and Drug Administration (FDA) has approved omacetaxine mepesuccinate subcutaneous injection (Synribo, Teva Pharmaceutical Industries) for the treatment of adult patients with chronic myeloid leukemia (CML) with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors (TKIs). Approval for omacetaxine mepesuccinate was granted on October 26, 2012.
The US Food and Drug Administration (FDA) approved regorafenib (Stivarga, Bayer HealthCare Pharmaceuticals, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemo­therapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib approval was granted on September 27, 2012.
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