In the News
On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first FDA approval in the adjuvant setting.
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.
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
Venetoclax plus Bortezomib and Dexamethasone Produces High Responses in Relapsed or Refractory Multiple Myeloma
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.
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Results 11 - 20 of 70
Results 11 - 20 of 70