01/23/2019

Recent Oncology Related FDA Approvals/Changes

• FDA approved cabozantinib (CABOMETYX, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. More Information.  January 14, 2019 (1)

• FDA approved tagraxofusp-erzs (ELZONRIS™, Stemline Therapeutics), a CD123-directed cytotoxin, for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. More information. December 21, 2019 (2)

• FDA approved ravulizumab-cwvz (ULTOMIRIS™, Alexion Pharmaceuticals, Inc.) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). More information. December 21, 2018 (2)

• FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. More Information. December 19, 2018 (2)

• FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). More Information.  December 19, 2018 (2)