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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Welcome to the Fourth Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
2019 Fourth Annual Oncology Guide to New FDA Approvals
The Lynx Group is pleased to bring you the
Fourth Annual Oncology Guide to New FDA Approvals
. The goal of this
Guide
is to offer oncologists, pharmacists, oncology nurses, and other healthcare stakeholders a comprehensive overview of new drugs approved by the US Food and Drug administration (FDA) in 2018 for the treatment of different types of cancer, including hematologic and oncologic malignancies. This practical tool offers a quick, evidence-based resource for hematology/oncology professionals to guide their medication-related decision-making and help ensure the administration of recent medicines for appropriate patients.
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New Indications Approved by the FDA in 2018 for Oncology Drugs
By
Dalia Buffery, MA, ABD
FDA Approvals, News & Updates
2019 Fourth Annual Oncology Guide to New FDA Approvals
Introduction
Oncology Overview
Breast Cancer New Indications
Genitourinary Cancers New Indications
Gynecologic Cancers New Indications
Hematologic Malignancies New Indications
Lung Cancer New Indications
Other Tumor Types New Indications
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FDA Approvals of Novel Brand-Name Prescription Cancer Drugs in 2018
FDA Approvals, News & Updates
,
FDA Approvals, News & Updates
2019 Fourth Annual Oncology Guide to New FDA Approvals
New Molecular Entities and New Biologic License Applications
New Oncology Biosimilars Approved in 2018
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Braftovi (Encorafenib) plus Mektovi (Binimetinib) Third BRAF/MEK Inhibition Combination Approved for Metastatic Melanoma with BRAF Mutation
FDA Approvals, News & Updates
2019 Fourth Annual Oncology Guide to New FDA Approvals
Melanoma is the most dangerous form of skin cancer. The 5-year relative survival rate for Americans with distant melanoma is only 23%. The National Cancer Institute estimated that there were 91,270 new cases of skin melanoma and more than 9300 deaths from this disease in 2018. This deadly disease is also costly; in the United States, expenditures for the treatment of melanoma exceeded $3 billion in 2018.
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Copiktra (Duvelisib) Approved for Relapsed or Refractory CLL, SLL, and Follicular Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
2019 Fourth Annual Oncology Guide to New FDA Approvals
Chronic lymphocytic leukemia (CLL) is a cancer of B-cell lymphocytes and is the most common type of leukemia in adults. More than 20,000 Americans were diagnosed with CLL in 2018.
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Daurismo (Glasdegib) Approved, in Combination with Low-Dose Cytarabine, for Newly Diagnosed Acute Myeloid Leukemia in Older Adults or Those Unfit for Intensive Chemotherapy
FDA Approvals, News & Updates
2019 Fourth Annual Oncology Guide to New FDA Approvals
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.
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Erleada (Apalutamide) First Drug Approved by the FDA for Nonmetastatic Castration-Resistant Prostate Cancer
FDA Approvals, News & Updates
2019 Fourth Annual Oncology Guide to New FDA Approvals
Prostate cancer, the second most common type of cancer in men, is expected to affect 11.6% of all men during their lifetime. In fact, more than 3 million men in the United States are living with prostate cancer. It is estimated that in 2017, 161,360 men were newly diagnosed with prostate cancer, and 26,730 men died from the disease.
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Imbruvica (Ibrutinib) plus Rituxan (Rituximab) New Combination Approved for the Treatment of Waldenström’s Macroglobulinemia
By
Lisa A. Raedler, PhD, RPh
FDA Approvals, News & Updates
,
Lymphoma
2019 Fourth Annual Oncology Guide to New FDA Approvals
In 1944, Jan G. Waldenström, MD, published his observations about a series of patients who presented with anemia, hepatosplenomegaly, hyperviscosity, bleeding, lymphoplasmacytic infiltrate in the bone marrow, and a large serum protein or “macroglobulin.” Today, Waldenström’s macroglobulinemia, also known as lymphoplasmacytic lymphoma, a type of non-Hodgkin lymphoma, is classified as a rare, indolent, and heterogeneous type of lymphoma of the lymphatic system.
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Infugem (Gemcitabine) First Formulation of Premixed, Ready-to-Administer Intravenous Chemotherapy Approved for Several Tumor Types
FDA Approvals, News & Updates
2019 Fourth Annual Oncology Guide to New FDA Approvals
Conventional cytotoxic chemotherapy works primarily by interfering with the division and growth of cells, including cancer cells and normal tissue. However, because it is nonselective, cytotoxic chemotherapy can damage healthy cells and can cause severe side effects. Recognizing this challenge, drug developers have been looking for new ways to deliver chemotherapy to address clinical and pharmacologic challenges in the administration of intravenous (IV) cytotoxic drugs, and selectively target cancer cells to improve clinical outcomes and reduce severe adverse events.
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Libtayo (Cemiplimab-rwlc), a PD-1 Inhibitor, First Drug Approved by the FDA for Patients with Advanced Cutaneous Squamous-Cell Carcinoma
FDA Approvals, News & Updates
2019 Fourth Annual Oncology Guide to New FDA Approvals
Cutaneous squamous-cell carcinoma (CSCC) is a type of nonmelanoma skin cancer that affects the squamous cells in the middle and outer layers of the skin. CSCC occurs most frequently on sun-exposed areas, such as the scalp, ears, lips, face, neck, and backs of the hands. Less often, CSCC can be in the skin of the genital area.
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Home
Issues
Online First
Latest Issue
Issue Archive
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Browse By Topic
Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
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Cholangiocarcinoma
View All Topics ›
Conference Correspondent
SABCS 2023 - HER2+ MBC
ASCO 2023 - Breast Cancer
Web Exclusives
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Prostate Cancer Diagnostics Monthly Minutes
Webinars
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Value-Based Care in Myeloma