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FDA OKs Launch of Phase III Tocilizumab Trial for COVID-19 Pneumonia

Jason M. Broderick @jasoncology
Published: Monday, Mar 23, 2020

The FDA has approved the initiation of a double-blind, randomized phase III clinical trial of the oncology supportive care drug tocilizumab (Actemra) for use in combination with standard of care for the treatment of hospitalized adult patients with severe COVID-19 pneumonia, according to Genentech (Roche), the manufacturer of the interleukin-6 receptor antagonist.1

Beyond CRS, tocilizumab also has FDA-approved indications for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

References           

  1. Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia. Posted March 23, 2020. https://www.gene.com/media/press-releases/14843/2020-03-23/genentech-announces-fda-approval-of-clin. Accessed March 23, 2020.
  2. U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma. Published February 13, 2020. https://bit.ly/39uYC0l. Accessed February 13, 2020.
  3. Wang ML, Munoz J, Goy A, et al. KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T cell therapy, in patients (pts) with relapsed/refractory (r/r) mantle cell lymphoma (MCL): results of the phase 2 zuma-2 study. Presented at: 2019 ASH Annual Meeting, Orlando, FL, December 7-10, 2019. Abstract 754.

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