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ASCO 2015 Highlights
Verzenio (Abemaciclib) a New CDK4/CDK6 Inhibitor Approved for HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer
By
Loretta Fala
Breast Cancer
,
FDA Approvals, News & Updates
,
Solid Tumors
2018 Third Annual Oncology Guide to New FDA Approvals
Breast cancer affects more women than any other type of cancer, and represents 15% of all new cancer cases in the United States. A total of 252,710 new breast cancer cases were estimated to be diagnosed in 2017, and more than 40,600 deaths. The prognosis worsens for patients with locally advanced breast cancer and even more so for those with metastatic disease.
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Tecentriq (Atezolizumab) Receives New Indication for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
By
Lisa A. Raedler, PhD, RPh
Bladder Cancer
,
FDA Approvals, News & Updates
2018 Third Annual Oncology Guide to New FDA Approvals
Urothelial carcinoma is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States. In 2017, more than 79,000 bladder cancer cases were diagnosed in the United States, and more than 16,000 people died from this disease. The prognosis is favorable for patients with localized disease, with a 5-year relative survival rate of 78% for all stages of bladder cancer, which decreases to 5% for patients with distant disease.
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Revlimid (Lenalidomide) First Drug Approved for Post-Transplant Maintenance Therapy in Multiple Myeloma
By
Lisa A. Raedler, PhD, RPh
FDA Approvals, News & Updates
,
Hematologic Malignancies
,
Multiple Myeloma
2018 Third 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 30,280 new cases of multiple myeloma will be diagnosed in 2017, and 12,590 deaths will be attributed to the disease. In the past 20 years, mortality rates associated with multiple myeloma have declined. Novel therapies, as well as improvements in autologous hematopoietic stem-cell transplantation (HSCT) procedures and supportive care, have contributed to extended survival for patients with this malignancy.
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Kymriah (Tisagenlecleucel) for Young Patients with Acute Lymphoblastic Leukemia: First FDA-Approved Gene Therapy
By
Loretta Fala
FDA Approvals, News & Updates
,
Leukemia
2018 Third Annual Oncology Guide to New FDA Approvals
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that affects the white blood cells (lymphocytes). In 2017, 5970 new patients were estimated to be diagnosed with ALL and 1440 individuals to die from this disease. ALL is diagnosed most often in children, adolescents, and young adults, with a median age of 15 years at diagnosis.
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Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer
By
Lisa A. Raedler, PhD, RPh
Breast Cancer
,
FDA Approvals, News & Updates
,
Solid Tumors
2018 Third Annual Oncology Guide to New FDA Approvals
Breast cancer is one of the most common cancer diagnoses in the United States. The National Cancer Institute estimates that 252,710 American women will be diagnosed with breast cancer and 40,610 will die from the disease in 2017. For the majority (62%) of women with breast cancer, the disease is confined to the breast, and the 5-year survival approaches 100%. However, for women with metastatic disease, the likelihood of survival at 5 years drops to 27%.
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Imfinzi (Durvalumab) a New PD-L1 Inhibitor Approved for the Treatment of Advanced or Metastatic Urothelial Cancer
By
Lisa A. Raedler, PhD, RPh
Bladder Cancer
,
FDA Approvals, News & Updates
2018 Third Annual Oncology Guide to New FDA Approvals
Urothelial carcinoma is the primary subtype of bladder cancer, which is the sixth most common cancer in the United States. More than 79,000 cases of bladder cancer were estimated to be diagnosed, and nearly 17,000 people to die from this disease in 2017.
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Imbruvica (Ibrutinib) First Drug Approved Specifically for Marginal-Zone Lymphoma and for Chronic Graft-versus-Host Disease
By
Lisa A. Raedler, PhD, RPh
FDA Approvals, News & Updates
,
Lymphoma
2018 Third Annual Oncology Guide to New FDA Approvals
Marginal-zone lymphoma (MZL) arises from B-lymphocytes in the marginal zone of lymphoid tissue. This slow-growing indolent B-cell lymphoma represents approximately 12% of all cases of non-Hodgkin lymphoma (NHL) in adults. MZL is divided into 3 subtypes, including mucosa-associated lymphoid tissue (MALT), nodal MZL, and splenic MZL. MALT lymphoma is the most common of these subtypes and occurs in the stomach, intestines, salivary glands, thyroid, eyes, and lungs. In MALT lymphoma, autoimmune processes or chronic infection cause B-cells to accumulate.
Helicobacter pylori
is 1 of at least 6 microbial species associated with lymphoproliferation in gastric MALT lymphoma.
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Calquence (Acalabrutinib) Approved for Relapsed or Refractory Mantle-Cell Lymphoma in Adults
By
Lisa A. Raedler, PhD, RPh
FDA Approvals, News & Updates
,
Lymphoma
2018 Third Annual Oncology Guide to New FDA Approvals
Mantle-cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma (NHL), comprising approximately ≥4% of NHL cases in the United States. Mantle-cell lymphoma most often affects men aged ≥60 years, and the key factors affecting prognosis include the patient’s age, performance status, lactate dehydrogenase levels, and white blood cell count.
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Alunbrig (Brigatinib) Approved for Metastatic NSCLC with ALK Mutation
By
Lisa A. Raedler, PhD, RPh
FDA Approvals, News & Updates
,
Lung Cancer
2018 Third Annual Oncology Guide to New FDA Approvals
Lung cancer is one of the most common cancers in men and women, and is the leading cause of cancer-related mortality in the United States. According to the American Cancer Society, more than 155,000 Americans will die from lung cancer in 2017, representing approximately 25% of all cancer deaths. Non–small-cell lung cancer (NSCLC), the most common form of the disease, accounts for 80% to 85% of all lung cancer cases.
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FDA Approvals of Brand-Name Prescription Cancer Drugs in 2017
FDA Approvals, News & Updates
2018 Third Annual Oncology Guide to New FDA Approvals
The cancer drugs included in this review were approved for the first time or received additional approvals by the US Food and Drug Administration in 2017 and are grouped here by several categories.
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Gaps in Biomarker Testing and Targeted Therapy for Gastric Cancer
Ashley Gamble, PhD
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John Perez, MBA, MSDS
Home
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