Hematologic Malignancies

Xospata (Gilteritinib) First Drug Approved as Monotherapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

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 ]

Tibsovo (Ivosidenib) First Targeted Therapy Approved for Patients with Relapsed or Refractory Acute Myeloid Leukemia and IDH1 Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

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 ]

Lumoxiti (Moxetumomab Pasudotox-tdfk) First CD22-Directed Cytotoxin FDA Approved for Relapsed or Refractory Hairy-Cell Leukemia

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

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 ]

Daurismo (Glasdegib) Approved, in Combination with Low-Dose Cytarabine, for Newly Diagnosed Acute Myeloid Leukemia in Older Adults or Those Unfit for Intensive Chemotherapy

Loretta Fala

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow that is characterized by the production of abnormal myeloblasts, red blood cells, or platelets. AML originates in the bone marrow, but it often spreads into the blood and to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. [ Read More ]

Gilteritinib a New Standard of Care for Relapsed or Refractory AML with FLT3 Mutation

Phoebe Starr

June 2019, Vol 10, No 3 - Leukemia

Atlanta, GA—Treatment with gilteritinib (Xospata) significantly improved overall survival (OS) with less toxicity compared with chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) and FLT3 mutation, according to the final results of ADMIRAL, a phase 3 clinical trial presented at the 2019 American Association for Cancer Research meeting. [ Read More ]

Paradigm Shift: Ibrutinib plus Rituximab Front-Line Therapy for Patients Age 70 or Younger with CLL

Phoebe Starr

June 2019, Vol 10, No 3 - Leukemia

San Diego, CA—The combination of the targeted therapy ibrutinib (Imbruvica), a protein kinase inhibitor, and the monoclonal antibody rituximab (Rituxan) extends disease-free survival by 65% and overall survival (OS) by 83% compared with standard-of-care chemotherapy with the fludarabine plus cyclophosphamide and rituximab (FCR) regimen as first-line therapy in patients with chronic lymphocytic leukemia (CLL) under age 70, according to results of the phase 3 ECOG-ACRIN 1912 trial presented at a late-breaking abstract session at ASH 2018. [ Read More ]

CAR T-Cell Therapy Augments Response to Ibrutinib in Chronic Lymphocytic Leukemia

Phoebe Starr

June 2019, Vol 10, No 3 - Leukemia

San Diego, CA—Results with chimeric antigen receptor (CAR) T-cell therapy have been less robust in chronic lymphocytic leukemia (CLL) compared with B-cell acute lymphocytic leukemia and diffuse large B-cell lymphoma. Preliminary studies presented at ASH 2018 suggested that a strategy of using CAR T-cell therapy to augment the response to ibrutinib (Imbruvica) holds promise in patients with CLL. [ Read More ]

Updated NCCN Treatment Guideline for CML Establishes Criteria for Stopping TKI Therapy

Wayne Kuznar

April 2019, Vol 10, No 2 - 2019 NCCN Conference, Leukemia

Orlando, FL—The discontinuation of a tyrosine kinase inhibitor (TKI) is considered safe and appropriate in consenting patients with chronic-phase chronic myeloid leukemia (CML) under specific circumstances and with careful molecular monitoring, according to the updated National Comprehensive Cancer Network (NCCN) management guideline for CML. [ Read More ]