FDA Approvals

On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).
On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow that is characterized by the production of abnormal myeloblasts, red blood cells, or platelets. AML originates in the bone marrow, but it often spreads into the blood and to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system.
Two human genes, BRCA1 and BRCA1 (BRCA1/2), produce proteins that block the growth of cancer, such as breast or ovarian cancer. These proteins ensure the stability of each cell’s genetic material and help to repair damaged DNA.
Another Approval for Keytruda
American Health & Drug Benefits is pleased to bring you the Tenth Annual Payers’ Guide to New FDA Approvals. As has now become a tradition of this publication, the goal of this Guide is to offer payers, providers, Pharmacy & Therapeutics committees, and other healthcare stakeholders an overview of the novel pharmaceuticals approved by the US Food and Drug Administration (FDA) in 2018.
Before we discuss the new indications for oncology therapies approved in 2018, a word about the novel drugs entering the market is in order, considering the new record set last year in drug approvals in the United States.
New Molecular Entities and New Biologic License Applications and New Biosimilars Approved in 2018
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
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