Drugs

Roche’s Giredestrant Shows Promise in Breast Cancer

Roche says its investigational breast cancer drug giredestrant met key goals in a pivotal Phase 3 study, showing significant benefits for patients with advanced estrogen receptor (ER)-positive disease. The evERA trial evaluated giredestrant in combination with everolimus against standard-of-care endocrine therapy plus everolimus in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer whose disease had progressed following treatment with a CDK4/6 inhibitor and endocrine therapy. ER-positive breast cancer represents roughly 70% of all breast cancer cases, the company says.

According to Roche, the trial achieved both of its co-primary endpoints — demonstrating a “statistically significant and clinically meaningful” improvement in progression-free survival in the overall patient group as well as in those with ESR1-mutated tumors. Early data on overall survival showed a positive trend but remain immature, it adds.

The all-oral drug combination was generally well tolerated, with side effects consistent with known safety profiles of the individual medicines, and no new safety concerns identified, Roche says.

Roche notes that evERA is the first Phase 3 head-to-head trial of a selective estrogen receptor degrader-containing regimen against a standard therapy combination to demonstrate positive results. The company plans to present detailed findings at an upcoming medical conference and submit the data to health regulators worldwide.

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