Leukemia

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

Phoebe Starr

January 2019, Vol 9, No 1 - Leukemia

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 the 2018 American Society of Hematology meeting. In addition, patients who received the chemotherapy-free, pill-based ibrutinib plus rituximab regimen had fewer adverse events than the patients who received FCR. [ Read More ]

Venclexta Approved in Combination for Older Adults with Acute Myeloid Leukemia

December 2018, Vol 8, No 12 - FDA Approvals, News & Updates, Leukemia

On November 21, 2018, the FDA accelerated the approval of venetoclax (Venclexta; AbbVie/Genentech), in combination with azacitidine (Vidaza), decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥75 years or those with comorbidities that preclude intensive induction chemotherapy. [ Read More ]

Daurismo New Treatment Approved for Older Adults with Acute Myeloid Leukemia

December 2018, Vol 8, No 12 - FDA Approvals, News & Updates, Leukemia

On November 21, 2018, the FDA approved glasdegib (Daurismo; Pfizer), an oral Hedgehog inhibitor, in combination with low-dose cytarabine (LDAC), for patients with newly diagnosed acute myeloid leukemia (AML) who are aged ≥75 years or who have comorbidities that preclude use of intensive induction chemotherapy. The FDA approved glasdegib using its priority review and granted it an orphan drug designation. [ Read More ]

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

Lisa A. Raedler, PhD, RPh

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 ]

Kymriah (Tisagenlecleucel) for Young Patients with Acute Lymphoblastic Leukemia: First FDA-Approved Gene Therapy

Loretta Fala

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

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that affects the white blood cells (lymphocytes). In 2017, 5970 new patients were estimated to be diagnosed with ALL and 1440 individuals to die from this disease. ALL is diagnosed most often in children, adolescents, and young adults, with a median age of 15 years at diagnosis. [ Read More ]

Besponsa a New Treatment Option for Patients with Relapsed/Refractory B-Cell ALL

October 2017, Vol 7, No 10 - FDA Approvals, News & Updates, Leukemia

On August 17, 2017, the FDA approved inotuzumab ozogamicin (Besponsa; Pfi­zer), a targeted therapy, for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The drug blocks cancer growth by binding to B-cell ALL cells that express CD22. The FDA designated inotuzumab ozogamicin as an orphan drug and applied its priority review for this approval. [ Read More ]