Daratumumab FDA Approved for Transplant-Eligible Patients With Multiple Myeloma

The FDA has now approved daratumumab (Darzalex®, Janssen) to be used in combination with bortezomib, thalidomide, and dexamethasone (VTd) in adult patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant. Daratumumab, a targeted monoclonal antibody, works by attaching itself to a protein called CD38 on multiple myeloma cells. This either directly kills the multiple myeloma cells or allows the body to identify these cells as a foreign invader, therefo...
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Apalutamide for Metastatic Castration-Sensitive Prostate Cancer: Kim N. Chi, MD

On September 17, 2019, the FDA approved apalutamide (Erleada®, Janssen Biotech, Inc.) in combination with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (CSPC). The approval was based on TITAN (NCT02489318), a Phase III clinical trial led by Kim N. Chi, MD, Vice President of BC Cancer Agency in Vancouver and Professor of Medicine at the University of British Columbia. In this interview with i3 Health, Dr. Chi discusses the significance of the...
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Apalutamide Approved for Metastatic Castration-Sensitive Prostate Cancer

The FDA has approved apalutamide (Erleada®, Janssen Biotech, Inc.) in combination with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (CSPC). The approval was based on TITAN (NCT02489318), a randomized, double-blind, placebo-controlled, multicenter clinical trial that enrolled 1,052 patients with metastatic CSPC, including patients with both high- and low-volume disease. Prior treatment for localized disease and prior docetaxel therapy were a...
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Lenvatinib Plus Pembrolizumab Approved for Advanced Endometrial Carcinoma

The FDA has approved lenvatinib (Lenvima®, Eisai) plus pembrolizumab (Keytruda®, Merck) for patients with advanced endometrial carcinoma who experience disease progression after at least one prior systemic therapy but are ineligible for curative surgery or radiation. Lenvatinib/pembrolizumab is indicated for patients whose cancer is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). "Lenvatinib is a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3, and other rece...
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Fedratinib Approved for Myelofibrosis

​ The FDA has now approved fedratinib (Inrebic®, Impact Biomedicines, Inc./Celgene Corporation) for the treatment of intermediate-2 or high-risk primary or secondary myelofibrosis. A myeloproliferative neoplasm, myelofibrosis can either present as a primary condition or as a secondary condition following the transformation of polycythemia vera or essential thrombocythemia. Myelofibrosis causes anemia, splenomegaly, and debilitating symptoms, and it shortens survival. "Prior to today, there was o...
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