In the News
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.
Glasdegib, a Hedgehog Inhibitor, Nearly Doubles Survival in Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
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.
A new economic model suggests that overall survival and drug toxicity profiles are insufficient for assessing the value of a drug. According to a study that incorporated late adverse events in advanced Hodgkin lymphoma, a more comprehensive benefit-to-risk ratio of a drug requires an understanding of its long-term health implications, said Ohad Oren, MD, Pennsylvania Hospital, University of Pennsylvania, Philadelphia, at the 2016 American Society of Hematology meeting.
The FDA has granted accelerated approval of rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, for the treatment of patients with advanced ovarian cancer whose tumors have deleterious BRCA gene mutation and have been treated with ≥2 chemotherapies. The administration also approved a companion diagnostic to the drug, FoundationFocus CDxBRCA, which is the first next-generation sequencing diagnostic test.
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Results 31 - 40 of 87
Results 31 - 40 of 87