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FDA Label Update Supports Earlier Use of Romiplostim for ITP

Jason M. Broderick @jasoncology
Published: Friday, Oct 18, 2019

The FDA has approved a supplemental Biologics License Application (sBLA) for romiplostim (Nplate), updating its label to include data demonstrating sustained platelet responses in adults with immune thrombocytopenia (ITP). Romiplostim is approved for the treatment of adult patients with newly diagnosed or persistent (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.1

All-grade adverse events that occurred in ≥25% of patients were contusion, upper respiratory tract infection, and oropharyngeal pain.

References

  1. Nplate® (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia. Amgen. Posted October 18, 2019. Accessed October 18, 2019. https://bit.ly/33DGf6s.
  2. FDA approves romiplostim for pediatric patients with immune thrombocytopenia. FDA. Posted December 14, 2018. Accessed October 18, 2019. https://bit.ly/2MP1dsq.
  3. Tarantino MD, Despotovic J, Roy J, et al. Safety and efficacy of romiplostim in over 200 children with immune thrombocytopenia (ITP): results of an integrated database of 5 clinical trials. In: Proceedings from the 2018 ASH Annual Meeting; December 1-4, 2018; San Diego, California. Abstract 2428.

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