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2022 Issues
February 2022 - Vol 15 No 1
2016 First Annual Oncology Guide to New FDA Approvals
Imlygic (Talimogene Laherparepvec): First Oncolytic Viral Therapy for the Treatment of Patients with Recurrent Melanoma
By
Lisa A. Raedler, PhD, RPh, Medical Writer
Drug Profiles
2016 First Annual Oncology Guide to New FDA Approvals
Melanoma represents the most dangerous form of skin cancer. According to recent data, the 5-year relative survival rate for Americans with distant melanoma is only 17%. The National Cancer Institute estimated that in 2015 there were 73,870 new cases of skin melanoma and more than 9900 patients died from this disease. In the United States, the total estimated national expenditures for the treatment of melanoma reached $2.8 billion in 2015.
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Imbruvica (Ibrutinib): First Drug Approved for the Treatment of Patients with Waldenström’s Macroglobulinemia
By
Lisa A. Raedler, PhD, RPh, Medical Writer
Drug Profiles
2016 First Annual Oncology Guide to New FDA Approvals
Waldenström’s macroglobulinemia (WM), also known as lymphoplasmacytic lymphoma, is an indolent subtype of B-cell non-Hodgkin lymphoma. WM is characterized by malignant B-cells that overproduce the abnormal monoclonal protein known as immunoglobulin (Ig) M or macroglobulin.
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Empliciti (Elotuzumab): First SLAMF7 Antibody Therapy Approved for the Treatment of Patients with Previously Treated Multiple Myeloma
By
Lisa A. Raedler, PhD, RPh, Medical Writer
Drug Profiles
2016 First Annual Oncology Guide to New FDA Approvals
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to the disease.
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Darzalex (Daratumumab): First Anti-CD38 Monoclonal Antibody Approved for Patients with Relapsed Multiple Myeloma
By
Lisa A. Raedler, PhD, RPh, Medical Writer
Drug Profiles
2016 First Annual Oncology Guide to New FDA Approvals
Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 26,800 new cases of multiple myeloma were diagnosed in 2015, and 11,240 deaths were attributed to the disease.
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Bendeka (Bendamustine Hydrochloride): Rapid-Infusion Formulation Approved for Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphomas
By
Lisa A. Raedler, PhD, RPh, Medical Writer
Drug Profiles
2016 First Annual Oncology Guide to New FDA Approvals
Chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (NHL) are common hematologic malignancies that represent a significant burden to patients and to the healthcare system. In light of the morbidity, mortality, and quality-of-life challenges associated with CLL and NHL, there is a marked need for additional therapeutic options for patients with these malignancies.
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Alecensa (Alectinib), an Oral Tyrosine Kinase Inhibitor, Approved for Metastatic Non–Small-Cell Lung Cancer with ALK Mutation
Drug Profiles
2016 First Annual Oncology Guide to New FDA Approvals
Lung cancer is the second most common cancer in the United States. In 2015, an estimated 221,200 new cases of lung cancer were diagnosed, representing 13.3% of all new cancer cases. Furthermore, lung cancer is the leading cause of cancer mortality in men and women, responsible for 27% of all cancer deaths, and claiming more lives than breast, colon, prostate, and ovarian cancers combined.
Read More ›
FDA Approvals of Brand-Name Prescription Drugs in 2015
FDA Updates
2016 First Annual Oncology Guide to New FDA Approvals
The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories.
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Translation of Benchtop Science Arrives in Force, Improves Patient Care
By
Val R. Adams, PharmD, FCCP, BCOP
2016 First Annual Oncology Guide to New FDA Approvals
The number of oncology trials seeking new indications for new and known agents is continuing to grow at a fevered pitch. The fruition of this work is now being realized; in the past 12 months, there have been 36 hematology/oncology drug approvals, 18 of which involved new drug entities.
Read More ›
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May 2024 - Vol 17 No 2
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December 2023 - Vol 16 No 6
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