FDA Approves Acalabrutinib for CLL and SLL

The FDA has just granted supplemental approval to acalabrutinib (Calquence®, AstraZeneca) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The main difference between CLL and SLL is where they occur in the body; CLL most often originates in the blood and bone marrow, and SLL occurs primarily in the lymph nodes. However, both of these diseases are cancers of lymphocytes—a type of immune cell that helps the body fight infection. Indications of CLL or SLL in...
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Zanubrutinib Approved for Mantle Cell Lymphoma

The FDA has approved zanubrutinib (Brukinsa®, BeiGene) for patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one previous therapy. The approval was based on two clinical trials. BGB-3111-206, a single-arm phase 2 trial, enrolled 86 patients with MCL whose disease progressed following at least one prior therapy. Patients received 160 mg of zanubrutinib orally twice daily until unacceptable toxicity or disease progression. The study's primary end point was ove...
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Niraparib Approved for Advanced HRD-Positive Ovarian Cancer

The FDA has approved niraparib (Zejula®, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who experience disease progression following three or more lines of chemotherapy. Niraparib is indicated for patients whose tumors are positive for homologous recombination deficiency (HRD). The approval was based on QUADRA (NCT02354586), a multicenter, open-label, single-arm, phase 2 trial that enrolled 463 patients with relapsed, high-grade serous epithelial o...
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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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