Hematologic Malignancies

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 ]

Revlimid (Lenalidomide) First Drug Approved for Post-Transplant Maintenance Therapy in Multiple Myeloma

Lisa A. Raedler, PhD, RPh

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

Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 30,280 new cases of multiple myeloma will be diagnosed in 2017, and 12,590 deaths will be attributed to the disease. In the past 20 years, mortality rates associated with multiple myeloma have declined. Novel therapies, as well as improvements in autologous hematopoietic stem-cell transplantation (HSCT) procedures and supportive care, have contributed to extended survival for patients with this malignancy. [ 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 ]

Daratumumab Therapy for Smoldering Myeloma Extends Progression-Free Survival

Wayne Kuznar

February 2018, Vol 9, No 1 | Payers’ Perspectives In Oncology: ASH 2017 Highlights - Multiple Myeloma

Atlanta, GA—Single-agent daratum­umab (Darzalex) shows significant activity in smoldering multiple myeloma (SMM). The 12-month progression-free survival (PFS) rate with a long dosing schedule of daratumumab was 95%, and the median PFS was not yet reached in any of the 3 dosing schedules studied, announced Craig C. Hofmeister, MD, MPH, Associate Professor, Division of Hematology, the Ohio State University, Columbus, at ASH 2017. [ Read More ]

Venetoclax plus Rituximab New Chemotherapy-Free Option for Chronic Lymphocytic Leukemia

Phoebe Starr

February 2018, Vol 9, No 1 | Payers’ Perspectives In Oncology: ASH 2017 Highlights - Leukemia

Atlanta, GA—Venetoclax (Venclexta) plus rituximab (Rituxan) achieved superior progression-free survival (PFS) and overall survival (OS) compared with standard-of-care bendamustine (Treanda/Bendeka) plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). PFS improved by 81% and OS by 52% with venetoclax plus rituximab, and the depth of response was impressive—complete response and complete response with incomplete platelet recovery was 26.8%, and minimal residual disease negativity in peripheral blood was 83.5%. [ Read More ]

New BTK Inhibitor Leads to Durable Responses in Relapsed or Refractory Chronic Lymphocytic Leukemia

Charles Bankhead

February 2018, Vol 9, No 1 | Payers’ Perspectives In Oncology: ASH 2017 Highlights - Leukemia

Atlanta, GA—More than 90% of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) achieved objective responses with the new Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence), updated data from an ongoing study showed. In most cases, the responses were durable, reported John C. Byrd, MD, Director, Division of Hematology, the Ohio State University Comprehensive Cancer Center, Columbus, at ASH 2017. [ Read More ]

Recent FDA Approvals for ALL a “Watershed” Moment

Chase Doyle

February 2018, Vol 9, No 1 | Payers’ Perspectives In Oncology: ASH 2017 Highlights - Leukemia

Atlanta, GA—The past few years have witnessed significant progress in the treatment of several hematologic malignancies, and truly paradigm-changing therapies have recently emerged in acute lymphoblastic leukemia (ALL). At ASH 2017, Crystal L. Mackall, MD, Co-Director, Immunology & Immunotherapy of Cancer Program, Stanford University, CA, discussed the FDA approvals of 2 important treatments for patients with B-cell precursor ALL. [ Read More ]

Ibrutinib plus Venetoclax Combo Elicits Impressive Responses in Relapsed Chronic Lymphocytic Leukemia

Wayne Kuznar

February 2018, Vol 9, No 1 | Payers’ Perspectives In Oncology: ASH 2017 Highlights - Leukemia

Atlanta, GA—Ibrutinib (Imbruvica) plus venetoclax (Venclexta) led to an objective response rate of 100% in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), with 47% in complete remission at 6 months. These high response rates were achieved with only 1 case of laboratory tumor lysis syndrome, said Peter Hillmen, MBChB, PhD, FRCP, FRCPath, Leader, Section of Experimental Haematology, Leeds Institute of Cancer and Pathology, United Kingdom, at ASH 2017. [ Read More ]

ASH Recaps “Phenomenal” Year for Acute Myeloid Leukemia Drug Approvals

Chase Doyle

February 2018, Vol 9, No 1 | Payers’ Perspectives In Oncology: ASH 2017 Highlights - Leukemia

Atlanta, GA—Although there have been major advancements in the treatment of hematologic malignancies in recent years, according to Richard Pazdur, MD, Director, FDA’s Oncology Center of Excellence, the number of agents approved in 2017 for acute myeloid leukemia (AML) was nothing short of “phenomenal.” [ Read More ]