On May 4, 2026, the U.S. Food and Drug Administration approved Guardant Health’s Guardant360® CDx liquid‑biopsy test as a companion diagnostic for VEPPANU (vepdegestrant), a therapy jointly developed by Arvinas and Pfizer. The approval applies to patients with estrogen‑receptor positive, HER2‑negative advanced breast cancer who carry ESR1 mutations, a subgroup that benefits from targeted therapy with VEPPANU.
VEPPANU, the first FDA‑approved PROTAC (proteolysis‑targeting chimera) therapy, received its own approval on May 1, 2026. The drug’s approval was backed by the Phase 3 VERITAC‑2 trial, which showed a median progression‑free survival of 5.0 months versus 2.1 months for fulvestrant, a hazard ratio of 0.57, and an objective response rate of 19% compared with 4% for fulvestrant.
Guardant Health’s recent financial results, released on May 7, 2026, showed revenue of $279.174 million and an earnings‑per‑share of $‑0.47. The company’s revenue grew 39.4% year‑over‑year to $281.27 million in the prior quarter, driven by a 30% increase in oncology revenue to $189.9 million. Guardant Health’s 2026 guidance calls for oncology revenue growth of 25% to 27% and screening revenue of $162 million to $174 million.
The approval expands Guardant Health’s portfolio of companion diagnostics, adding a third ESR1‑targeted test and reinforcing its strategy of pairing diagnostics with targeted therapies. The new approval is expected to create a high‑margin revenue stream tied to the growing precision‑oncology market.
Arvinas and Pfizer plan to select a third‑party partner to commercialize VEPPANU, a move that could accelerate market penetration. The drug competes with other ESR1‑mutated therapies such as Orserdu (elacestrant) and Eli Lilly’s Imlunestrant, and targets a patient subgroup that represents up to 40‑50% of endocrine‑therapy‑treated ER+/HER2‑negative breast cancer patients.
Helmy Eltoukhy, Guardant Health chairman and co‑CEO, said the approval “reflects where cancer care is headed using blood‑based testing to detect resistance earlier and guide smarter treatment decisions.” Randy Teel, Arvinas CEO, noted that VEPPANU “is the first‑ever approved PROTAC therapy” and that the company is “on track to announce a third‑party partner for commercialization.” Erika Hamilton, MD, added that the new treatment “brings renewed hope to individuals who need additional options.”
The FDA approval of Guardant360® CDx for VEPPANU underscores the growing importance of liquid‑biopsy diagnostics in oncology and signals a continued shift toward precision medicine. For Guardant Health, the approval strengthens its high‑margin precision‑oncology portfolio and positions the company to capture a larger share of the expanding ESR1‑mutation market.
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