Drugs

AstraZeneca Wins Accelerated Approval for Breast Cancer Drug

FDA has granted AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. The approval applies to patients who have an estrogen receptor-1 (ESR1) mutation. The agency also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with the mutation.

Approval was supported by data from the SERENA-6 (NCT04964934), a randomized, double-blind, placebo-controlled, multicenter trial involving 315 patients, according to FDA. “The primary efficacy outcome measure was investigator-assessed progression-free survival (PFS) per RECIST v1.1,” it says. “An additional efficacy outcome measure included overall survival (OS). Median PFS was 16 months (95% CI: 12.7, 18.2) in the camizestrant and CDK4/6 inhibitor arm and 9.2 months (95% CI: 7.2, 9.5) in the AI and CDK4/6 inhibitor arm (Hazard ratio 0.44 [95% CI: 0.31, 0.60]; p-value < 0.00001). At the time of the PFS analysis, OS data were not mature.”

The approved labeling includes a Boxed Warning for the risk of arrhythmia due to QTc interval prolongation when concomitantly used with QTc interval-prolonging drugs, as well as warnings and precautions for bradycardia and embryo-fetal toxicity.

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