06/18/2019

Recent Oncology Related FDA Approvals/Changes

• FDA granted accelerated approval to pembrolizumab (KEYTRUDA,  Merck) for patients with metastatic small cell lung cancer (SCLC) with disease  progression on or after platinum-based chemotherapy and at least one other prior  line of therapy. More Information.  June 17, 2019.

• FDA approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). More Information.  June 10, 2019

• FDA granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. More Information. June 10, 2019

• 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