Drugs

Positive Results in AZ Breast Cancer Trials

AstraZeneca has reported positive high-level results from the SERENA-2 Phase 2 trial and the CAPitello-291 Phase 3 trial of new breast cancer drugs. The company says the SERENA-2 trial showed that AZ’s next-generation oral selective estrogen receptor degrader camizestrant met the primary endpoint of demonstrating a statistically significant and clinically meaningful progression-free survival benefit at 75mg and 150mg dose levels versus the company’s Faslodex (fulvestrant) 500mg in post-menopausal patients with estrogen receptor-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy for advanced disease.

AZ says camizestrant was well tolerated and its safety profile was consistent with that observed in previous trials with no new safety signals identified.

For the CAPitello-291 trial, AZ says capivasertib combined with Faslodex demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus placebo plus Faslodex in patients with HR-positive, HER2-low or negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy, with or without a CDK4/6 inhibitor.

The trial met both primary endpoints, the company says, and the capivaserib safety profile was similar to that observed in previous trials evaluating the combination.

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