Lisa A. Raedler, PhD, RPh


Authored Items

Kadcyla (Ado-Trastuzumab Emtansine): First Antibody-Drug Conjugate Approved for the Treatment of HER2-Positive Metastatic Breast Cancer

June 2013, Vol 4, No 5 - Drug Updates

Approximately 25% of women who are diagnosed with breast cancer have HER2-positive tumors. The HER2 gene, which resides on chromosome 17, directs tumor cells to manufacture HER2 protein. This protein is a cell-surface receptor that compels the tumor cell to grow and to divide more frequently than normal, making HER2-positive breast cancer an aggressive phenotype.

Before the advent of HER2-directed therapies, patients diagnosed with HER2-positive disease had significantly shorter disease-free survival compared with patients with other breast cancer subtypes.1

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Xofigo (Radium Ra 223 Dichloride): The First Alpha Particle–Emitting Radioactive Agent for the Treatment of Castration-Resistant Prostate Cancer with Symptomatic Bone Metastases

July 2013, Vol 4, No 6 - Drug Updates

Prostate cancer is the second leading cause of cancer-related death in the United States among men and the most frequently diagnosed cancer in American males. Among patients with metastatic prostate cancer, up to approximately 90% have bone metastases.1 The median survival after the diagnosis of bone metastasis associated with prostate cancer is approximately 3 years.2

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Tafinlar and Mekinist: Two Oral Targeted Kinase Inhibitors for the Treatment of Patients with Metastatic Melanoma and BRAF Mutations

September 2013, Vol 4, No 7 - Drug Updates

Cutaneous melanoma, although not the most common skin cancer, is the most deadly.1 Based on data collected between 2003 and 2009, the 5-year survival rate for Americans with metastatic melanoma remains very low—only 16%—for all disease stages and for both sexes.2 The National Cancer Institute has estimated that approximately 1 in 49 people will be diagnosed with melanoma in the United States, and more than 9450 people will die of this disease in 2013.2

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Revlimid Receives a New Indication for the Treatment of Patients with Relapsed or Progressing Mantle-Cell Lymphoma

October 2013, Vol 4, No 8 - Drug Updates

Mantle-cell lymphoma (MCL), which accounts for approximately 6% of new non–Hodgkin lymphoma diagnoses, is a rare and often aggressive cancer.1,2 MCL is most often diagnosed in older white adults (typically patients are in their mid-60s) and is usually in advanced stages.1,2 Splenomegaly and lymph node enlargement are typically present, in addition to bone marrow, liver, and gastrointestinal tract involvement.2

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Gilotrif: Second-Generation Tyrosine Kinase Inhibitor Indicated for the First-Line Treatment of Patients with Non–Small-Cell Lung Cancer and EGFR Mutation

November 2013, Vol 4, No 9 - Drug Updates

Lung cancer is one of the most frequently diagnosed cancers, as well as the leading cause of cancer-related mortality in the United States.1 The American Cancer Society has estimated that more than 159,000 Americans will die from lung cancer in 2013, representing approximately 27% of all cancer deaths.1 Non–small-cell lung cancer (NSCLC), the most common form of the disease, accounts for 85% to 90% of all cases of lung cancer.2

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Abraxane Receives a New Indication for the Treatment of Patients with Metastatic Pancreatic Cancer

February 2014, Vol 5, No 1 - Drug Updates

The American Cancer Society has estimated that approximately 45,220 new cases of pancreatic cancer would be diagnosed in the United States in 2013 and approximately 38,460 patients would die of pancreatic cancer in 2013.1 Despite being the tenth most common cancer, pancreatic cancer is the fourth most common cause of cancer deaths, in part because a large majority of patients present with nonresectable advanced disease.2,3

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Gazyva for Chronic Lymphocytic Leukemia: First FDA-Approved Breakthrough Therapy in Oncology

March 2014, Vol 5, No 2 - Drug Updates

Chronic lymphocytic leukemia (CLL), a monoclonal disorder characterized by progressive accumulation and proliferation of functionally incompetent B-cells, is the most frequently diagnosed leukemia in the United States. The American Cancer Society has estimated that 4580 Americans will die from CLL in 2013, which represents approximately 19% of all leukemia deaths. Because it can have an insidious onset, CLL is often discovered incidentally after blood work is conducted for another reason. Between 25% and 50% of patients with CLL are asymptomatic at the time of presentation. [ Read More ]

Imbruvica (Ibrutinib) the First Bruton’s Tyrosine Kinase Inhibitor Approved for Treatment of Patients with Relapsed Chronic Lymphocytic Leukemia

May 2014, Vol 5, No 4 - Drug Updates

Chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults, is a cancer of B-cell lymphocytes, which originate in the bone marrow, develop in the lymph nodes, and normally fight infection by producing an immune response. In CLL, excess B-cells accumulate in the bone marrow and blood, where they crowd out healthy blood cells. [ Read More ]

Jakafi (Ruxolitinib): First FDA-Approved Medication for the Treatment of Patients with Polycythemia Vera

June 2015, Vol 6, No 5 - Drug Updates

Similar to myelofibrosis and essential thrombocythemia, polycythemia vera is a Philadelphia chromosome–negative myeloproliferative neoplasm. Polycythemia vera is characterized by the clonal stem-cell proliferation of red blood cells, white blood cells, and platelets. Increased red blood cell mass results in the hyperviscosity of the blood, an increased risk for thrombosis, poor quality of life, and a shortened life expectancy. [ Read More ]

Ibrance (Palbociclib): First CDK4 and CDK6 Inhibitor FDA Approved for the Treatment of Postmenopausal Women with Metastatic Breast Cancer

August 2015, Vol 6, No 7 - Drug Updates

Breast cancer is one of the most common cancer diagnoses in the United States. The National Cancer Institute estimates that 231,840 American women will be diagnosed with breast cancer, and nearly 40,300 women will die from the disease in 2015. Overall, 61% of women with breast cancer are diagnosed while the disease is confined to the breast; for these women, the 5-year survival rate is 98.6%. However, for women with metastatic breast cancer, the 5-year survival rate falls sharply, to 26%. [ Read More ]

Onivyde (Irinotecan Liposome Injection) a New Treatment Option for Patients with Metastatic Pancreatic Cancer

March 2016, Vol 7, No 2 - Drug Updates

There is an urgent unmet need for more effective therapies in pancreatic cancer. The American Cancer Society estimated that approximately 49,000 new cases of pancreatic cancer will be diagnosed in the United States in 2015, and more than 40,500 people will die from this cancer.1 Pancreatic cancer is the fourth most common cause of cancer deaths in the United States. [ Read More ]

Tecentriq (Atezolizumab) First PD-L1 Inhibitor Approved for Patients with Advanced or Metastatic Urothelial Carcinoma

September 2016, Vol 7, No 8 - Drug Updates

Urothelial carcinoma (also known as transitional-cell carcinoma) is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States. In 2016, nearly 77,000 cases of bladder cancer are expected to be diagnosed in the United States, and more than 16,000 people will die from this disease. The incidence of bladder cancer increases with age, with a median age of 73 years at diagnosis. [ Read More ]

Alunbrig (Brigatinib) Approved for Metastatic NSCLC with ALK Mutation

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lung Cancer

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. [ Read More ]

Calquence (Acalabrutinib) Approved for Relapsed or Refractory Mantle-Cell Lymphoma in Adults

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lymphoma

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. [ Read More ]

Imbruvica (Ibrutinib) First Drug Approved Specifically for Marginal-Zone Lymphoma and for Chronic Graft-versus-Host Disease

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lymphoma

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. [ Read More ]

Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer

2018 Third Annual Oncology Guide to New FDA Approvals - Breast Cancer, FDA Approvals, News & Updates

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%. [ Read More ]

Revlimid (Lenalidomide) First Drug Approved for Post-Transplant Maintenance Therapy in Multiple Myeloma

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Multiple Myeloma

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. [ Read More ]

Tecentriq (Atezolizumab) Receives New Indication for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

2018 Third Annual Oncology Guide to New FDA Approvals - Bladder Cancer, FDA Approvals, News & Updates

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. [ Read More ]

Vyxeos (Daunorubicin and Cytarabine) Liposomal Combination First Treatment Approved for Patients with High-Risk Acute Myeloid Leukemia

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

Acute myeloid leukemia (AML) is a rare but deadly cancer. Approximately 21,400 new cases of AML were diagnosed in 2017 in the United States, and nearly 10,600 people died from the disease. Approximately 60% to 70% of adults with AML respond to initial treatment with cytotoxic chemotherapy. However, the 5-year survival rate for patients with AML remains poor at approximately 27%. [ Read More ]

Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Ovarian Cancer

In ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer, malignant cells form in the tissue covering the ovary or lining the fallopian tube or peritoneum. According to the American Cancer Society, in 2017 more than 22,000 women in the United States were estimated to be diagnosed with these cancers and more than 14,000 to die from them. [ Read More ]