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Lisa A. Raedler, PhD, RPh
Authored Items
Padcev (Enfortumab Vedotin-ejfv) FDA Approved for the Treatment of Metastatic Urothelial Carcinoma
By
Lisa A. Raedler, PhD, RPh
2020 Oncology Drug Coding and Updates
Drug Updates
Urothelial carcinoma, also known as transitional-cell carcinoma (TCC), is the most common subtype of bladder cancer. Based on data from 2016, more than 80,000 cases of bladder cancer were estimated to be diagnosed in the United States in 2019, and approximately 17,600 patients were expected to die from this disease.
Read More ›
Xospata (Gilteritinib) First Drug Approved as Monotherapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
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%.
Read More ›
Vitrakvi (Larotrectinib) First TRK Inhibitor Approved by the FDA for Solid Tumors Based on a Genetic Mutation
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
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.
Read More ›
Udenyca (Pegfilgrastim-cbqv) Second Biosimilar Approved to Reduce the Incidence of Infection Associated with Febrile Neutropenia
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
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.
Read More ›
Tibsovo (Ivosidenib) First Targeted Therapy Approved for Patients with Relapsed or Refractory Acute Myeloid Leukemia and IDH1 Mutation
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
Leukemia
,
FDA Approvals, News & Updates
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%.
Read More ›
Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
Breast Cancer
,
FDA Approvals, News & Updates
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.
Read More ›
Lutathera (Lutetium Lu 177 Dotatate) First Radioactive Drug Approved for Gastroenteropancreatic Neuroendocrine Tumors
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
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.
Read More ›
Lumoxiti (Moxetumomab Pasudotox-tdfk) First CD22-Directed Cytotoxin FDA Approved for Relapsed or Refractory Hairy-Cell Leukemia
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
Leukemia
,
FDA Approvals, News & Updates
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.
Read More ›
Infugem (Gemcitabine) First Formulation of Premixed, Ready-to-Administer Intravenous Chemotherapy Approved for Several Tumor Types
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
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.
Read More ›
Imbruvica (Ibrutinib) plus Rituxan (Rituximab) New Combination Approved for the Treatment of Waldenström’s Macroglobulinemia
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
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.
Read More ›
Copiktra (Duvelisib) Approved for Relapsed or Refractory CLL, SLL, and Follicular Lymphoma
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
Leukemia
,
FDA Approvals, News & Updates
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.
Read More ›
Braftovi (Encorafenib) plus Mektovi (Binimetinib) Third BRAF/MEK Inhibition Combination Approved for Metastatic Melanoma with BRAF Mutation
By
Lisa A. Raedler, PhD, RPh
2019 Fourth Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
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.
Read More ›
Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
Read More ›
Vyxeos (Daunorubicin and Cytarabine) Liposomal Combination First Treatment Approved for Patients with High-Risk Acute Myeloid Leukemia
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
Read More ›
Tecentriq (Atezolizumab) Receives New Indication for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
Read More ›
Revlimid (Lenalidomide) First Drug Approved for Post-Transplant Maintenance Therapy in Multiple Myeloma
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
,
Multiple Myeloma
Read More ›
Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
Breast Cancer
,
FDA Approvals, News & Updates
Read More ›
Imfinzi (Durvalumab) a New PD-L1 Inhibitor Approved for the Treatment of Advanced or Metastatic Urothelial Cancer
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
Read More ›
Imbruvica (Ibrutinib) First Drug Approved Specifically for Marginal-Zone Lymphoma and for Chronic Graft-versus-Host Disease
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
,
Lymphoma
Read More ›
Calquence (Acalabrutinib) Approved for Relapsed or Refractory Mantle-Cell Lymphoma in Adults
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
,
Lymphoma
Read More ›
Alunbrig (Brigatinib) Approved for Metastatic NSCLC with ALK Mutation
By
Lisa A. Raedler, PhD, RPh
2018 Third Annual Oncology Guide to New FDA Approvals
FDA Approvals, News & Updates
,
Lung Cancer
Read More ›
Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer
By
Lisa A. Raedler, PhD, RPh
September 2017, Vol 7, No 9
Breast Cancer
Read More ›
Imbruvica (Ibrutinib) First Drug Approved Specifically for Marginal-Zone Lymphoma
By
Lisa A. Raedler, PhD, RPh
August 2017, Vol 7, No 8
Drug Updates
Marginal-zone lymphoma (MZL) is a malignancy that 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.
Read More ›
Real-World Experience with Taiho Oncology Patient Support for Lonsurf® (trifluridine and tipiracil)
By
Lisa A. Raedler, PhD, RPh
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. As insurance benefit designs continue to shift the cost burden of treatment, more patients with cancer and their families are both psychologically and financially invested in treatment decisions.
Read More ›
Sustol First Extended-Release 5-HT3 Receptor Antagonist Approved for the Prevention of Acute and Delayed CINV
By
Lisa A. Raedler, PhD, RPh
December 2016, Vol 6, No 12
Drug Updates
Read More ›
Cabometyx (Cabozantinib) Tablets First Multikinase Inhibitor Approved for the Treatment of Patients with Advanced Renal-Cell Carcinoma
By
Lisa A. Raedler, PhD, RPh
November 2016, Vol 6, No 11
Drug Updates
Read More ›
Tecentriq (Atezolizumab) First PD-L1 Inhibitor Approved for Patients with Advanced or Metastatic Urothelial Carcinoma
By
Lisa A. Raedler, PhD, RPh
October 2016, Vol 6, No 10
Drug Updates
Read More ›
Venclexta (Venetoclax) First BCL-2 Inhibitor Approved for High-Risk Relapsed Chronic Lymphocytic Leukemia
By
Lisa A. Raedler, PhD, RPh
September 2016, Vol 6, No 9
Drug Updates
Read More ›
Empliciti (Elotuzumab): First SLAMF7 Antibody Therapy Approved for the Treatment of Patients with Previously Treated Multiple Myeloma
By
Lisa A. Raedler, PhD, RPh
May 2016, Vol 6, No 5
Drug Updates
Read More ›
Darzalex (Daratumumab): First Anti-CD38 Monoclonal Antibody Approved for Patients with Relapsed Multiple Myeloma
By
Lisa A. Raedler, PhD, RPh
April 2016, Vol 6, No 4
Drug Updates
,
Hematologic Malignancies
,
Multiple Myeloma
Read More ›
Ninlaro (Ixazomib): First Oral Proteasome Inhibitor Approved for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
By
Lisa A. Raedler, PhD, RPh
March 2016, Vol 6, No 3
Drug Updates
Read More ›
Onivyde (Irinotecan Liposome Injection) a New Treatment Option for Patients with Metastatic Pancreatic Cancer
By
Lisa A. Raedler, PhD, RPh
February 2016, Vol 6, No 2
Drug Updates
Read More ›
Keytruda (Pembrolizumab) First PD-1 Inhibitor Approved for the Treatment of Patients with Metastatic Non–Small-Cell Lung Cancer Expressing PD-L1
By
Lisa A. Raedler, PhD, RPh
January 2016, Vol 6, No 1
Drug Updates
Read More ›
Nurse Navigator Perspective
By
Lisa A. Raedler, PhD, RPh
Patient Assistance Profiler December 2014
Read More ›
Ibrance (Palbociclib): First CDK4 and CDK6 Inhibitor FDA Approved for the Treatment of Postmenopausal Women with Metastatic Breast Cancer
By
Lisa A. Raedler, PhD, RPh
October 2015, Vol 5, No 7
Breast Cancer
,
Drug Updates
Read More ›
Jakafi (Ruxolitinib): First FDA-Approved Medication for the Treatment of Patients with Polycythemia Vera
By
Lisa A. Raedler, PhD, RPh
June 2015, Vol 5, No 5
Drug Updates
Read More ›
Akynzeo (Netupitant and Palonosetron), a Dual-Acting Oral Agent, Approved by the FDA for the Prevention of Chemotherapy-Induced Nausea and Vomiting
By
Lisa A. Raedler, PhD, RPh
May 2015, Vol 5, No 4
Drug Updates
Read More ›
Overview of Onyx 360 Patient Assistance Program
By
Lisa A. Raedler, PhD, RPh
Patient Assistance Profiler December 2014
Read More ›
Zydelig (Idelalisib): First-in-Class PI3 Kinase Inhibitor Approved by the FDA for the Treatment of 3 Hematologic Malignancies
By
Lisa A. Raedler, PhD, RPh
December 2014, Vol 4, No 8
Drug Updates
Read More ›
Beleodaq (Belinostat) Receives FDA Approval for the Treatment of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
By
Lisa A. Raedler, PhD, RPh
November 2014, Vol 4, No 7
Drug Updates
Read More ›
Arzerra (Ofatumumab) Receives FDA Approval for Patients with Previously Untreated Chronic Lymphocytic Leukemia for Use in Combination with Chlorambucil
By
Lisa A. Raedler, PhD, RPh
October 2014, Vol 4, No 6
Drug Updates
Read More ›
Zykadia (Ceritinib) Approved for the Treatment of Patients with Crizotinib-Resistant ALK-Positive Non–Small-Cell Lung Cancer
By
Lisa A. Raedler, PhD, RPh
August 2014, Vol 4, No 5
Drug Updates
Read More ›
Imbruvica (Ibrutinib) the First Bruton’s Tyrosine Kinase Inhibitor Approved for the Treatment of Patients with Relapsed Chronic Lymphocytic Leukemia
By
Lisa A. Raedler, PhD, RPh
June 2014, Vol 4, No 4
Drug Updates
Read More ›
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