Drug Updates

FDA Approves Split-Dosing Regimen for Daratumumab in Patients with Multiple Myeloma

Drug Updates, FDA Approvals, News & Updates, In the News

On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion. [ 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 - Drug Updates, 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 ]

Tecentriq (Atezolizumab) First PD-L1 Inhibitor Approved for Patients with Advanced or Metastatic Urothelial Carcinoma

Lisa A. Raedler, PhD, RPh

September 2016, Vol 7, No 8 - Drug Updates

Urothelial carcinoma (also known as transitional-cell carcinoma) is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States. In 2016, nearly 77,000 cases of bladder cancer are expected to be diagnosed in the United States, and more than 16,000 people will die from this disease. The incidence of bladder cancer increases with age, with a median age of 73 years at diagnosis. [ Read More ]

Defitelio (Defibrotide Sodium): First Drug Approved for Patients with Hepatic Veno-Occlusive Disease

Laura Morgan

July 2016, Vol 7, No 6 - Drug Updates

Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome, is a rare and life-threatening liver condition that is characterized by rapid weight gain, ascites, painful hepatomegaly, and jaundice. It is often observed in patients after allogeneic or autologous hematopoietic stem-cell transplantation (HSCT), and has also been reported during the treatment of Wilms tumor, rhabdomyosarcoma associated with actinomycin D, and acute lymphoblastic leukemia. [ Read More ]