New FDA Approvals: FDA Approves First Erleada Generic

Apr 10
Apr 10, 2025

March 17: The FDA approved Zydus Lifesciences Limited’s apalutamide 60 mg tablets for the treatment of people with metastatic castration-sensitive prostate cancer. The androgen receptor inhibitor is the first FDA-approved generic of Johnson & Johnson’s Erleada. Dosing of the tablet is 240 mg once daily. Erleada also is approved for the treatment of nonmetastatic castration-resistant prostate cancer, as well as a 240 mg tablet. Drugs.com lists the price of 120 60 mg tablets and 30 240 mg tablets of Erleada as more than $15,982.

March 19: The FDA granted traditional approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test. The agency gave the programmed death receptor-1 (PD-1) inhibitor accelerated approval for this indication on May 5, 2021; the drug’s first approval overall was Sept. 4, 2014. This application has orphan drug designation, and its review used the Assessment Aid. Dosing for this use is 200 mg every three weeks or 400 mg every six weeks. The list price for every-three-weeks dosing is $11,564.16; every-six-weeks dosing is $23,138.32.
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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.