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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.
  • FDA Approves First Therapy for the Treatment of Adult Patients with a Rare Blood Clotting Disorder
  • FDA Issues Letter to Healthcare Providers Alerting Them to a Risk for Breast Implant Associated–Anaplastic Large-Cell Lymphoma
  • FDA Resumes Operations After Government Shutdown Ends
  • FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
  • FDA Approves Pembrolizumab for Merkel-Cell Carcinoma
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold.
In the FDA’s dynamic regulatory environment, the patient voice has been adopted and end points for clinical trials have evolved from overall survival to other efficacy measures. “Having multiple drugs is a good thing. Many are approved on nonsurvival end points, and they have transformed the diseases,” said Richard Pazdur, MD.
The CALGB/Alliance 50303 clinical trial failed to show that dose-adjusted treatment with the EPOCH-R (etoposide, phosphate, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride, and rituximab) regimen was superior to standard therapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone) in patients with diffuse large B-cell lymphoma (DLBCL). Both treatment regimens were equally effective for event-free survival and overall survival (OS), but dose-adjusted
The addition of venetoclax (Venclexta) to bortezomib (Velcade) and dexamethasone yields high response rates in patients with relapsed or refractory multiple myeloma, especially in patients with disease that is not refractory to bortezomib and who received 1 to 3 previous lines of therapy, according to findings presented by Philippe Moreau, MD, Department of Hematology, Nantes University Hospital, France, at the 2016 American Society of Hematology meeting.

Although tyrosine kinase inhibitors (TKIs), including imatinib (Gleevec), nilotinib (Tasigna), and dasatinib (Sprycel), have dramatically improved outcomes in patients with chronic myeloid leukemia (CML), the costs of these drugs have spiraled out of control, causing some patients to stop treatment or cut their dosage because of financial toxicity. Data presented at the 2016 American Society of Hematology meeting show that it is possible for some patients with CML to reduce their TKI dose by 50% and maintain remission, perhaps even stop treatment altogether once deep and durable remission has been achieved after approximately 5 years of treatment.
Delaying medication processing is common, especially when it comes to oral cancer therapies. Oncologists at 3 oncology clinics looked at such barriers and the potential impact on patient outcomes.
Adding the investigational smoothened (SMO) receptor inhibitor glasdegib to low-dose cytarabine (Depo­Cyt) significantly increased overall survival (OS) compared with low-dose cytarabine monotherapy in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who were ineligible for intensive chemotherapy, according to a phase 2 study presented by Jorge E. Cortes, MD, Department of Leukemia, M.D. Anderson Cancer Center, Houston, TX, at the 2016 American Society of Hematology meeting.
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