FDA Policy/General

Lilly Gets Expanded Indication for Verzenio

FDA has approved an expanded indication for Eli Lilly’s Verzenio (abemaciclib), in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with hormone receptor-positive human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence. The expanded indication for high-risk patients eligible for Verzenio “can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are equal to or larger than 5cm or Grade 3),” the company says. It also removes the Ki-67 score (the percentage of positively stained tumor cells among the total number of malignant cells assessed) requirement for patient selection.

Lilly says the label expansion is based on data from the Phase 3 monarchE trial of adjuvant Verzenio in combination with ET, “which showed a deepened benefit in invasive disease-free survival (IDFS) beyond the two-year treatment course with adjuvant Verzenio… At four years, 85.5% of patients remained recurrence-free with Verzenio plus ET, compared to 78.6% with ET alone, an absolute difference in IDFS of 6.9%.”

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