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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