06/04/2019

Recent Oncology Related FDA Approvals/Changes

• FDA approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. More Information.  May 29, 2019

• FDA approved lenalidomide (REVLIMID, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). More Information. May 28, 2019

• FDA approved alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. More Information. May 24, 2019

• FDA approved ruxolitinib (JAKAFI, Incyte Corporation) for  steroid-refractory acute graft-versus-host disease (GVHD) in adult and  pediatric patients 12 years and older. More Information.  May 24, 2019

• FDA approved dalteparin sodium (FRAGMIN, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. More Information. May 16, 2019

• FDA approved approved venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)..More Information.  May 15, 2019

• FDA approved avelumab (BAVENCIO, EMD Serono, Inc.) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). More Information.  May 14, 2019

• FDA approved ramucirumab (CYRAMZA, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib. More Information.  May 10, 2019