New Cancer Drug Vepdegestrant Gets FDA Approval

The U.S. Food and Drug Administration approved vepdegestrant, sold under the brand name Veppanu, on 1 May 2026 for adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer. The drug was developed by Arvinas Operations, Inc. and Pfizer Inc., and it is the first FDA-approved Proteolysis Targeting Chimera drug.

Approved Use and Patient Group

Vepdegestrant is an oral therapy for patients whose disease has progressed after at least one line of endocrine therapy. The approval applies to patients identified by an FDA-authorised test for ESR1 mutations.

Companion Diagnostic and Mutation Testing

The FDA also approved Guardant360 CDx on 1 May 2026 as a companion diagnostic device for identifying patients with breast cancer who have ESR1 mutations. Companion diagnostics are laboratory tests used to select patients for a specific medicine or treatment.

Clinical Trial and Drug Class

The approval was based on the Phase 3 VERITAC-2 trial, registered as NCT05654623. In the ESR1-mutated patient group, vepdegestrant showed a median progression-free survival of 5.0 months compared with 2.1 months for fulvestrant, and the objective response rate was 19% versus 4%.

Important Facts for Exams

• PROTAC stands for Proteolysis Targeting Chimera, a class of protein-degrading medicines.
• Vepdegestrant is an oral heterobifunctional protein degrader therapy.
• QTc interval prolongation and embryo-fetal toxicity are listed as warnings and precautions for vepdegestrant.
• The FDA approved the application one month ahead of its goal date using the Assessment Aid process.

Dose and Safety Information

The recommended dose of vepdegestrant is 200 mg taken orally once daily with food until disease progression or unacceptable toxicity. QTc interval prolongation and embryo-fetal toxicity are included in the safety information for the drug.