FDA Accepts Application for Subcutaneous Rituximab
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Explore This IssueJanuary 2017
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The FDA has accepted the biologics license application (BLA) for the subcutaneous formulation of rituximab (Rituxan), with an action date of June 26, 2017.3 The BLA was accepted subsequent to updated study results from the Phase 3 SABRINA trial, which compared subcutaneous and intravenous rituximab in previously untreated follicular lymphoma oncology patients. Data from this study were presented at the American Society of Hematology Annual Meeting, Dec. 3–6.
Etanercept Approved for Pediatric Plaque Psoriasis
The FDA has approved the supplemental BLA for etanercept (Enbrel) to treat pediatric patients (ages 4–17) with chronic moderate to severe plaque psoriasis.4 This agent is the first systemic treatment for patients at this age and with this condition. The approval was based on results from a one-year, Phase 3 study along with a five-year, open-label extension study, which evaluated the efficacy and safety of etanercept in patients aged 4–17 with chronic moderate to severe plaque psoriasis.
Adverse events seen in these pediatric patients were similar to those seen in prior studies in adults with moderate to severe plaque psoriasis.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Villiger PM, Adler S, Kuchen S, et al. Tocilizumab for induction and maintenance of remission in giant cell arteritis: A Phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2016; 387(10031):1921–1927.
- Adler S, Reichenbach S, Kuchen S, et al. Termination of tocilizumab treatment in giant cell arteritis: Follow-up of patients after the RCT (ClinicalTrials.gov registration number: NCT01450137) [abstract]. Arthritis Rheumatol. 2016;68 (Suppl 10).
- Genentech Inc. News release: Genentech showcases new clinical data across a variety of blood diseases at American Society of Hematology 2016 Annual Meeting. 2016 Nov 3.
- Amgen Inc. News release: FDA approves expanded use of Enbrel (etanercept) to treat children with chronic moderate to severe plaque psoriasis. FirstWord Pharma. 2016 Nov 4.
Editor’s note: These briefs were previously published on our website.