FDA Approvals, News & Updates

  • First HDAC Inhibitor, Panobinostat, Approved for the Treatment of Patients with Multiple Myeloma
  • Palbociclib Approved for Metastatic Breast Cancer in Postmenopausal Women
  • FDA Expedites Approval of Lenvatinib for Refractory Differentiated Thyroid Cancer
  • Lenalidomide plus Dexamethasone Receives Expanded Indication for Patients with Newly Diagnosed Myeloma
  • Nivolumab First Immuno­therapy to Get FDA Approval for Metastatic Lung Cancer
A Payers’ Guide to New FDA Approvals is published annually by American Health & Drug Benefits to offer payers and other healthcare stakeholders a detailed analysis of new drugs approved by the US Food and Drug Administration (FDA) in the previous year, as well as a preview of some of the key trends in the 2015 drug pipeline.
On January 8, 2014, the US Food and Drug Administration (FDA) approved the use of dabrafenib (Tafinlar; GlaxoSmithKline) plus trametinib (Mekinist; GlaxoSmithKline) as a new combination therapy for the treatment of patients with advanced melanoma that is unresectable or metastatic.
On January 12, 2014, the FDA approved a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least 1 previous therapy, using the agency’s accelerated approval process.
On April 17, 2014, the FDA approved ofatumumab (Arzerra Injection; Glaxo­SmithKline), in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
On April 21, 2014, the FDA approved ramucirumab (Cyramza; Eli Lilly) for the treatment of patients with advanced stomach cancer or gastro­esophageal junction adenocarcinoma.
On April 29, 2014, the FDA approved ceritinib (Zykadia; Novartis) for the treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC).
On May 28, 2014, the FDA approved a new indication for palonosetron HCl (Aloxi; Eisai) injection for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) associated with initial or repeated courses of emetogenic chemotherapy in children aged 1 month to
On July 3, 2014, the FDA approved belinostat (Beleodaq; Spectrum Pharmaceuticals) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).
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