Veppanu Approved for Advanced Breast Cancer

The US Food and Drug Administration (FDA) has approved Veppanu^™ (vepdegestrant – Arvinas, Inc.), an proteolysis‑targeting chimera (PROTAC) therapy, on May 1, 2026 for the treatment of adults who have estrogen receptor‑positive, human epidermal growth factor receptor 2‑negative (ER+/HER2‑), estrogen receptor-1 (ESR1)‑mutated advanced or metastatic breast cancer, as detected by an FDA‑authorized test, following disease progression on at least one line of endocrine therapy. This is the first oral PROTAC selective estrogen receptor degraders (SERDs) that causes full estrogen‑receptor degradation mechanism. Approval was granted approximately one month ahead of the assigned PDUFA date, utilizing the FDA Assessment Aid. The FDA also approved Guardant Health’s Guardant360 CDx as a companion diagnostic to identify patients with ESR1‑mutated breast cancer eligible for treatment. The recommended dose is 200mg taken orally once daily with food until disease progression or unacceptable toxicity. Pricing and detailed launch timing have not yet been announced. For complete prescribing information, see here.

At a Glance

• Brand Drug:  Veppanu™ (vepdegestrant)
• Manufacturer: Arvinas, Inc. (in collaboration with Pfizer)
• Date Approved: May 1, 2026
• Indication: For adults who have ER+/HER2, ESR1‑mutated advanced or metastatic breast cancer, as detected by an FDA‑authorized test, following progression on at least one line of endocrine therapy
• Dosage Forms Available: 100mg and 200mg oral tablets
• Launch Date: Not yet announced; Arvinas and Pfizer are currently selecting a third‑party commercialization partner
• Estimated Annual Cost: Not yet disclosed
• FDA Designation: Priority Review
• Breast cancer remains one of the most commonly diagnosed cancers among women in the US, with approximately 382,600 cases per year. Around 70% are ER+/HER2‑ representing the most common molecular subtype.
• Endocrine therapy often incorporating aromatase inhibitors is a cornerstone of treatment for ER+/HER2‑ advanced breast cancer; however, treatment resistance remains a major clinical challenge in up to 50% of patients, particularly in later lines of therapy.
• ESR1 mutations emerge as a key mechanism of endocrine resistance, particularly following exposure to endocrine therapy and cyclin-dependent kinase (CDK)4/6 inhibitors. This mutation is associated with disease progression and limited treatment options.
• In the clinical trial that led to approval, Veppanu significantly improved progression‑free survival (PFS) compared with fulvestrant, an injectable selective estrogen receptor degrader (SERD), in patients who had ESR1‑mutated disease, reducing the risk of disease progression or death by approximately 43% with a median PFS of five months versus 2.1 months. Overall survival data were too early at the time of approval.
• Warnings and precautions include QT interval prolongation, embryo‑fetal toxicity and laboratory abnormalities.
• The most common side effects include changes in blood counts and liver tests, muscle or joint pain, fatigue, nausea, reduced appetite, constipation, low potassium levels and changes seen on heart rhythm tests (QT prolongation).
• Currently approved oral SERDs for ESR1‑mutated ER+/HER2‑ metastatic breast cancer include Orserdu^® (elacestrant – Radius Health) and Inluriyo^® (imlunestrant – Eli Lilly) offering oral alternatives to injectable endocrine therapy following progression.
• There are multiple pipeline therapies that could challenge Veppanu including oral SERDs at advanced stages of development. These include AstraZeneca’s camizestrant with anticipated FDA decision in the first half of 2026, Genentech’s giredestrant with an FDA action date of Dec. 18, 2026 and Olema Pharmaceuticals’ palazestrant in phase III development with a potential approval timeline around 2027. Camizestrant’s review follows a recent FDA advisory committee discussion that underscored ongoing uncertainty around clinical benefit in the evolving HR+/HER2‑ advanced breast cancer landscape.