The Babak Lab shared a post on LinkedIn:
“Clinical Mondays: Vepdegestrant in ESR1-mutated breast cancer.
The FDA has approved Vepdegestrant (Veppanu) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on at least one line of endocrine therapy.
Key Focus: The approval introduces the first oral estrogen receptor PROTAC degrader for patients with ESR1-mutated disease.
Key Insights:
- Approval was based on the phase
- Patients received Vepdegestrant once daily or Fulvestrant
- mPFS was 5.0 months with Vepdegestrant vs 2.1 months with Fulvestrant
- ORR was 19% vs 4% in the respective arms
- Guardant360 CDx was also approved as a companion diagnostic to identify ESR1 mutations
Conclusion:
This approval adds a new targeted endocrine option for ESR1-mutated ER+/HER2 – advanced breast cancer.
Image generated using Sora by OpenAI.”
To which Maria (Masha) Babak, Head of The Babak Lab and Assistant Professor at City University of Hong Kong, added:
“Lipinski said No, Veber said Yes. The first PROTAC therapy will reach patients! Looking forward to longer-term outcomes and data.”
Title: FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Other article about The Babak Lab and Maria (Masha) Babak OncoDaily.