Wednesday, June 1, 2022

U.S. Food and Drug Administration Oncology Drugs Update

You are subscribed to Oncology Drugs for U.S. Food and Drug Administration. This information has recently been updated, and is now available.

 

On May 27, 2022, FDA granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 

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FDA also approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC):

  • nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-based chemotherapy
  • nivolumab in combination with ipilimumab (Yervoy, Bristol-Myers Squibb Company)

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