Leukemia

Gilteritinib and CX-01 in the Treatment of Patients with Acute Myeloid Leukemia

Phoebe Starr

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - Leukemia

Chicago, IL—Gilteritinib (Xospata), a recently approved FLT3 inhibitor, prolonged survival in patients with relapsed or refractory acute myeloid leukemia (AML) and an FLT3 mutation in the phase 3 ADMIRAL clinical trial. A new analysis presented at ASCO 2019 was focused on the impact of baseline co-mutations and FLT3-ITD allelic burden on overall response and on overall survival (OS) in patients with relapsed or refractory AML who received treatment with gilteritinib. [ Read More ]

Fixed-Duration Targeted Therapy with Venetoclax plus Obinutuzumab New Front-Line Standard for Patients with Chronic Lymphocytic Leukemia

Phoebe Starr

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - Leukemia

Chicago, IL—In the phase 3 CLL14 trial, fixed-duration therapy with the combination of venetoclax (Venclexta) plus obinutuzumab (Gazyva) was superior to the combination of chemotherapy with chlorambucil plus obinutuzu­mab as front-line therapy in older patients with chronic lymphocytic leukemia (CLL) and comorbidities. Kirsten Fischer, MD, Center for Integrated Oncology Cologne-Bonn, University Hospital, Germany, presented the study results at ASCO 2019 and were published simultaneously (Fischer K, et al. N Engl J Med. 2019;380:2225-2236). [ Read More ]

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 ]