Selinexor Approved for R/R Diffuse Large B-Cell Lymphoma

Accelerated approval was granted to selinexor (Xpovio®, Karyopharm Therapeutics) to treat adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including those with DLBCL resulting from follicular lymphoma, after receiving at least two prior lines of systemic therapy. Selinexor had previously been approved in combination with dexamethasone for adult patients with R/R multiple myeloma who were previously treated with at least four therapies and whose disease is refr...
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Tumor-Induced Osteomalacia: Burosumab-twza Approved

The FDA has approved burosumab-twza (Crysvita®, Ultragenyx Pharmaceutical, Inc.), a fully human monoclonal antibody, for the treatment of patients aged two and older with tumor-induced osteomalacia (TIO) whose tumors are unable to be located or removed. A rare condition, TIO develops when tumors secrete high levels of fibroblast growth factor 23 (FGF23), a peptide hormone–like substance which lowers phosphate levels, thereby weakening and softening the bones. Patients with TIO can experience bon...
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Tazemetostat for Follicular Lymphoma Granted Accelerated Approval

Tazemetostat (TAZVERIK™, Epizyme, Inc.) has been approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have tumors that are positive for an EZH2 mutation, have received at least 2 previous systemic therapies, and have no satisfactory alternative treatment options. In addition, the FDA approved the cobas® EZH2 Mutation Test (Roche Molecular Systems, Inc.) as a companion diagnostic for tazemetostat. An EZH2 inhibitor, tazemetostat has previously been approved f...
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Ken Kato, MD, PhD: FDA Approval of Nivolumab for Esophageal Squamous Cell Carcinoma

The FDA recently approved nivolumab for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior fluoropyrimidine- and platinum-based chemotherapy. Ken Kato, MD, PhD, lead author on the study the approval was based on, spoke to i3 Health about the challenges of treating this patient population, in addition to the significance of this approval. What are the most challenging aspects of treating patients with advanced ESCC refra...
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Gemtuzumab Ozogamicin Approved for Pediatric Acute Myeloid Leukemia

The FDA has extended the approval of gemtuzumab ozogamicin (MylotargTM, Wyeth Pharmaceuticals, LLC) to include pediatric patients aged 1 month and older with newly diagnosed CD33-positive acute myeloid leukemia (AML). Gemtuzumab ozogamicin is a humanized immunoconjugate that targets CD33, a cell surface antigen present in over 80% of patients with AML. The approval was based on AAML0531 (NCT00372593), a phase 3 trial that enrolled 1,063 patients aged 0 to 29 years with newly diagnosed AML. Patie...
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