In the News

At the end of November, the FDA approved elotuzumab (Empliciti) for use in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received 1 to 3 previous medications. Elotuzumab is the second FDA-approved monoclonal antibody for patients with multiple myeloma; the first agent (daratumumab) was approved earlier in the month.
On January 21, 2015, secukinumab (Cosentyx; Novartis), a human IL-17A antagonist, was approved by the US Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe plaque psoriasis.
Ixazomib (Ninlaro) has been approved for use in combination with lenalidomide (Revlimid) and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 previous therapy. This is the first oral proteasome inhibitor to be approved for this patient population.
Daratumumab (Darzalex) received accelerated approval for patients with multiple myeloma who have received ≥3 treatments, according to the FDA. This is the first monoclonal antibody approved for multiple myeloma.
Lung cancer is the leading cause of cancer-related mortality in the United States among men and women. The most common type of the disease, non–small-cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases.
The US Food and Drug Administration (FDA) today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
  • 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.
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