Drugs

Veppanu Approved for Advanced Breast Cancer

FDA has approved Arvinas Operations’ Veppanu (vepdegestrant) for treating certain patients with advanced breast cancer, marking the first authorization of a heterobifunctional protein degrader in this setting. The approval action covers adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy. Patients must be identified using an FDA-authorized test, with the agency simultaneously clearing the Guardant360 CDx as a companion diagnostic to detect ESR1 mutations.

The approval is based on results from the Phase 3 VERITAC-2 trial, which enrolled 624 patients with ER-positive, HER2-negative advanced or metastatic breast cancer, according to an agency release. Among the 270 patients with ESR1-mutated tumors, treatment with vepdegestrant demonstrated a statistically significant improvement in progression-free survival compared with fulvestrant, a commonly used endocrine therapy.

Median progression-free survival reached 5 months in the vepdegestrant arm, compared with 2.1 months for fulvestrant, translating to a 43% reduction in the risk of disease progression or death, FDA says. The objective response rate was also higher with the investigational therapy, at 19% versus 4% for fulvestrant. Overall survival data remain immature, with only 16% of events recorded at the time of analysis.

Vepdegestrant is administered orally once daily and represents a novel therapeutic approach designed to degrade the estrogen receptor protein, rather than simply inhibit it, the release says. The drug is intended for use following progression on prior endocrine therapy, including regimens containing CDK4/6 inhibitors, which are standard in earlier lines of treatment.

Safety findings identified risks consistent with endocrine-targeting agents, including warnings for QTc interval prolongation and embryo-fetal toxicity, according to prescribing information.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome