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FDA Approves Single-Dose Aprepitant Regimen for MEC

Gina Columbus @ginacolumbusonc
Published: Tuesday, Oct 22, 2019

The FDA has expanded the approval of aprepitant (Cinvanti) injectable emulsion for intravenous (IV) use to include the 130-mg single-dose regimen for patients receiving moderately epigenetic chemotherapy (MEC).

Specifically, results showed that patients who received aprepitant reported fewer adverse events (AEs) than those who received IV fosaprepitant, including substantially fewer infusion-site reactions.

References

  1. Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC). Heron Therapeutics, Inc. Published October 22, 2019. https://finance.yahoo.com/news/heron-announces-fda-approval-supplemental-123000083.html. Accessed October 22, 2019.
  2. Ottoboni T, Lauw M, Keller MR, Cravets M, Manhard K, Clendeninn N, Quart B. HTX-019 via 2-min injection or 30-min infusion in healthy subjects [published online ahead of print December 21, 2018]. Future Med. doi: 10.2217/fon-2018-0809.
  3. Heron Therapeutics Announces U.S. FDA Approval of CINVANTI (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV). Heron Therapeutics. Published November 9, 2017. https://bit.ly/2NyINfA. Accessed February 28, 2019.
  4. Ottoboni T, Boccia G, Keller MR, Cravets M, Clendeninn N, Quart B. Bioequivalence of HTX-019 (aprepitant IV) and fosaprepitant in healthy subjects. Presented at: 2017 Hematology/Oncology Pharmacy Association Annual Conference; March 29-April 1, 2017; Anaheim, CA.

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