New FDA Specialty Approvals

May 29: The FDA expanded the label of Eli Lilly and Co.’s Cyramza (ramucirumab) to include, in combination with erlotinib, the first-line treatment of people with metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 (L858R) mutations. Dosing is 10 mg/kg via intravenous infusion every two weeks with daily erlotinib. The monthly list price for this indication is $11,103. Visit www.cyramza.com.

June 10: The FDA gave another indication to Bristol-Myers Squibb Co.’s Opdivo (nivolumab) for people with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. The recommended dose is a 240 mg intravenous infusion every two weeks or 480 mg every four weeks. Website Drugs.com lists the price of a 240 mg/24 mL vial as $6,879.49. Visit www.opdivo.com.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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