Major FDA approval: 'Veppanu', the first PROTAC therapy for breast cancer, receives approval

  • On May 1, 2026, the U.S. Food and Drug Administration (FDA) granted approval to vepdegestrant (brand name: Veppanu), marking a significant milestone in breast cancer treatment.
  • This drug is specifically approved for treating adult patients with advanced or metastatic breast cancer that is estrogen receptor-positive (ER-positive), HER2-negative, and harbors an ESR1 gene mutation.
  • The drug was jointly developed by Arvinas Operations, Inc. and Pfizer Inc.
  • Notably, this is the world's first drug based on Proteolysis Targeting Chimera (PROTAC) technology to receive FDA approval.
  • Vepdegestrant is an oral medication approved for patients whose disease has progressed following at least one line of endocrine therapy.
  • The drug is intended for use only in patients who have been confirmed to have an ESR1 gene mutation via an FDA-authorized test.
  • This approval is considered a significant step towards personalized and more precise cancer treatment.

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