VEPPANU, jointly developed by Arvinas, Inc. and Pfizer Inc., is approved for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

The approval of Guardant360 CDx enables a non-invasive, blood-based method to identify patients with ESR1 mutations who may be eligible for treatment with VEPPANU. ESR1 mutations are a known mechanism of resistance to endocrine therapy and are commonly observed in patients with advanced disease.

"This latest FDA approval using Guardant360 CDx reflects where cancer care is headed using blood-based testing to detect resistance earlier and guide smarter treatment decisions," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "By identifying ESR1 mutations with just a simple blood draw, we're helping bring more precise, personalized options to patients when they need them most."

Vepdegestrant, discovered by Arvinas and co-developed with Pfizer, is a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. It is designed to selectively degrade the estrogen receptor, offering a targeted treatment option for patients whose cancers are driven by ESR1 mutations. The approval is supported by clinical data demonstrating the clinical utility of identifying ESR1 mutations to guide treatment selection in ER+/HER2- advanced breast cancer.

This latest FDA approval for Guardant360 CDx marks the third ESR1 companion diagnostic approval. It is the 26th companion diagnostic indication across multiple tumor types, building on the platform's increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.