Lisa A. Raedler, PhD, RPh
Authored Items
2019 Fourth Annual Oncology Guide to New FDA Approvals
Acute myeloid leukemia (AML) is a rare but deadly hematologic cancer. In 2018, approximately 19,500 new cases of AML were diagnosed, and more than 10,600 people died from the disease in the United States. Although up to 70% of adults with AML have a complete response to initial treatment with cytotoxic chemotherapy, the responses are not durable. The 5-year survival rate for people with AML is only 24%.
2019 Fourth Annual Oncology Guide to New FDA Approvals
Gene mutations or rearrangements in the tropomyosin receptor kinase (TRK) family of receptor tyrosine kinases are emerging as an important driver of cancer-cell growth in a wide range of cancers. Research has shown that neurotrophic receptor tyrosine kinase (NTRK) genes, which encode for TRK proteins, can fuse abnormally to other genes and enhance cell signals that support tumor growth. NTRK gene fusions are found in a variety of tumor types, including soft-tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer, and lung cancer.
2019 Fourth Annual Oncology Guide to New FDA Approvals
Febrile neutropenia is a serious complication of cancer chemotherapy that can require treatment delays and chemotherapy dose reductions, which compromise the efficacy of treatment. Among patients with cancer who are receiving chemotherapy, approximately 1% have febrile neutropenia. This condition affects patient morbidity and mortality and its clinical management requires significant healthcare resources.
2019 Fourth Annual Oncology Guide to New FDA Approvals
Acute myeloid leukemia (AML) is a rare but deadly cancer. In 2018, approximately 19,500 new cases of AML were estimated to be diagnosed in the United States and more than 10,600 people to die from the disease. Clinical trials data show that up to 70% of adults with AML have disease that completely responds to initial treatment with cytotoxic chemotherapy. However, the 3-year survival rate for patients with AML remains poor, at approximately 25%.
2019 Fourth Annual Oncology Guide to New FDA Approvals
Two human genes, BRCA1 and BRCA2 (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. A mutation in either BRCA results in these proteins not functioning correctly. Specifically, DNA damage may not be repaired effectively, which can lead to cancer.
2019 Fourth Annual Oncology Guide to New FDA Approvals
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), also known as carcinoids and islet-cell tumors, are tumors of the neuroendocrine cells that occur in the gastrointestinal (GI) tract. GEP-NETs are heterogeneous and complex. Although relatively rare, GEP-NETs are more common than other tumors of the GI tract, including stomach and pancreatic carcinomas combined.
2019 Fourth Annual Oncology Guide to New FDA Approvals
Hairy-cell leukemia (HCL) is a rare and indolent hematologic cancer. HCL, which is 4 to 5 times more frequent in men than in women, accounts for 2% of all leukemias. Approximately 1000 new cases of HCL are diagnosed in the United States annually.
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.
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
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.
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.
2018 Third Annual Oncology Guide to New FDA Approvals
On April 28, 2017, the FDA accelerated the approval of brigatinib (Alunbrig; Takeda Oncology), a new-generation oral ALK inhibitor, for the treatment of patients with ALK-positive metastatic NSCLC who do not tolerate or have had an inadequate response to crizotinib.
2018 Third Annual Oncology Guide to New FDA Approvals
On October 31, 2017, the FDA granted an accelerated approval for acalabrutinib (Calquence; AstraZeneca), an oral BTK inhibitor, for the treatment of adults with mantle-cell lymphoma who have received at least 1 therapy.
2018 Third Annual Oncology Guide to New FDA Approvals
On January 19, 2017, the FDA granted accelerated approval of a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with relapsed or refractory MZL who require systemic therapy after at least 1 anti-CD20–based therapy.
2018 Third Annual Oncology Guide to New FDA Approvals
On May 1, 2017, the FDA granted accelerated approval to durvalumab (Imfinzi; AstraZeneca), an intravenous (IV) PD-L1 inhibitor, for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
2018 Third Annual Oncology Guide to New FDA Approvals
On February 22, 2017, the US Food and Drug Administration (FDA) approved lenalidomide (Revlimid; Celgene), an oral IMiD, for maintenance therapy after autologous HSCT in patients with multiple myeloma.
2018 Third Annual Oncology Guide to New FDA Approvals
On August 3, 2017, the FDA granted an accelerated approval for the new combination of daunorubicin and cytarabine liposome (Vyxeos; Jazz Pharmaceuticals), an intravenously infused drug, for the treatment of adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.
2018 Third Annual Oncology Guide to New FDA Approvals
Using its priority review process, on March 27, 2017, the FDA approved niraparib (Zejula; Tesaro), an oral PARP inhibitor, for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors have completely or partially responded to platinum-based chemotherapy.
Patient Assistance Profiler™ – December 2016
As the costs associated with cancer care continue to escalate, all key stakeholders—healthcare providers, private and government payers, and patients—strive to balance high-quality cancer care with cost efficiency.
Supplement October 2014 Vol 5, No 5
A multidisciplinary roundtable was convened on May 29, 2014, to gain insight and guidance from experts on the diagnosis and management of polycythemia vera (PV), including practical strategies, recent advances, and the emerging science.
June 2014 Vol 5, No 3
Memphis, TN—During the first day of the Fourth Annual Navigation and Survivorship Conference of the Academy of Oncology Nurse Navigators (AONN) in Memphis, Tennessee, the meeting co-chairs, Lillie D. Shockney, RN, BS, MAS, University Distinguished Service Associate Professor of Breast Cancer at Johns Hopkins University; Program Director of the Academy of Oncology Nurse & Patient Navigators (AONN+), and Sharon Gentry, RN, MSN, AOCN, CBCN, Breast Health Navigator, Derrick L. Davis Forsyth Regional Cancer Center, reviewed accomplishments and painted a compelling picture of the future of AONN+ as an organization.
June 2014 Vol 5, No 3
Memphis, TN—In order to ensure high-quality patient-centered healthcare, oncology navigators must know patients’ needs and understand the factors that influence whether and how those needs are met. Systematic assessment of cancer patients’ needs is integral to navigators’ role in addressing cancer patients’ needs effectively.
April 2014 Vol 5, No 2
Memphis, TN—One of the most popular presentations at the 4th Annual Navigation and Survivorship Conference of the Association of Oncology Nurse & Patient Navigators (AONN+) was delivered by Linda A. Lee, MD, AGAF. Dr Lee is the Clinical Director of the Division of Gastroenterology and Hepatology at Johns Hopkins Integrative Medicine and Digestive Center in Baltimore.
April 2014 Vol 5, No 2
Memphis, TN—On Sunday, November 17, 2013, a series of breakout sessions were conducted to highlight navigation challenges in the context of specific tumor types. Experts in the development of navigation programs and services for patients with breast cancer, colorectal cancer, gynecologic cancer, pediatric oncology, and others shared their experiences and advice.
February 2014 Vol 5, No 1
Memphis, TN—The final address of the Fourth Annual Conference of the Academy of Oncology Nurse & Patient Navigators (AONN+) in Memphis, Tennessee, was delivered by Deforia Lane, PhD, MT-BC. Dr Lane is the Associate Director of the Seidman Cancer Center, and Director of Music Therapy at University Hospitals of Cleveland, Seidman Cancer Center, and Rainbow Babies & Children’s Hospital. She is also an opera singer and breast cancer survivor.
February 2014 Vol 5, No 1
Memphis, TN—One of the most popular breakout sessions at the Fourth Annual Conference of the Academy of Oncology Nurse & Patient Navigators (AONN+) focused on breast cancer navigation and survivorship. This session featured 2 speakers, Karen Meneses, PhD, RN, FAAN, and Vinnie Myers, a tattoo artist.
December 2013 Vol 4, No 6
Lisa A. Raedler, PhD, RPh, shares best practices for facilitating compliance with new Commission on Cancer Standards 3.1 and 3.3.
Last modified: March 26, 2021