Drugs

FDA Approves Lilly Combo for Metastatic Breast Cancer

FDA has granted Eli Lilly full approval for the combination use of Inluriyo (imlunestrant) with Verzenio (abemaciclib) in adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Approval was based on data from the EMBER-3 (NCT04975308) study, a randomized, open-label, active-controlled, multicenter trial that enrolled 874 adults with ER-positive, HER2-negative, locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor either alone or in combination with a CDK4/6 inhibitor

“Patients were randomized 1:1:1 to imlunestrant, an investigator’s choice of endocrine therapy (fulvestrant or exemestane), or imlunestrant in combination with abemaciclib,” the agency says. “The major efficacy outcome measure for the combination of imlunestrant with abemaciclib was investigator-assessed progression-free survival (PFS) according to RECIST v1.1 in the overall population, comparing imlunestrant plus abemaciclib to imlunestrant monotherapy. Other efficacy outcome measures included overall survival (OS) and investigator-assessed objective response rate (ORR).”

FDA says that in an “exploratory subgroup analysis in 159 patients with ESR1 mutated tumors for the combination, the PFS HR estimate was 0.53 (95% CI: 0.35, 0.80). Median PFS in patients with ESR1 mutated tumors was 11.1 months (95% CI: 7.4, 13.7) in the imlunestrant and abemaciclib arm and 5.5 months (95% CI: 3.8, 7.2) in the imlunestrant alone arm. ORR was 35% (95% CI: 22, 48) and 15% (95% CI: 7, 23) in the respective arms.”

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