New FDA Specialty Approvals

May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma. The agency gave the application priority review, and the review was conducted through the Real-Time Oncology Review (RTOR) pilot program. The FDA first approved the programmed cell death-1 (PD-1) inhibitor on Sept. 4, 2014. The recommended dose of Keytruda is 200 mg every three weeks or 400 mg every six weeks via a 30-minute intravenous infusion. The list price for the every-three-weeks dosing is $9,869.94; for every six weeks, it’s $19,739.88.

May 14: The FDA approved Apellis Pharmaceuticals, Inc.’s Empaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) who are treatment naïve, as well as people switching from any C5 inhibitors, including Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz). Empaveli is the first C3 inhibitor for PNH. The agency gave the drug priority review, as well as fast track and orphan drug designations. The recommended dose is 1,080 mg twice weekly via subcutaneous infusion using an infusion pump. The drug’s annual wholesale acquisition cost is $458,000.

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Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (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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