Drugs

Enhertu Combo Delays Breast Cancer Progression

A new combination therapy involving AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) and pertuzumab (Genentech’s Perjeta) has significantly extended progression-free survival for patients with HER2-positive metastatic breast cancer, according to results from the Phase 3 DESTINY-Breast09 trial presented 5/31 at the American Society of Clinical Oncology annual meeting. The study marks the first time in over a decade that a new treatment has demonstrated improved outcomes in the first-line setting for a broad population of patients with this aggressive form of breast cancer, AstraZeneca says.

In a prespecified interim analysis, the Enhertu-pertuzumab combination reduced the risk of disease progression or death by 44% compared to the current standard regimen of taxane, trastuzumab, and pertuzumab (THP), the company says. Median progression-free survival was 40.7 months for the Enhertu group versus 26.9 months for those receiving THP, it adds. The combination also produced a higher confirmed objective response rate (85.1% vs. 78.6%), with more complete responses (58 vs. 33) and a longer median duration of response — 39.2 months versus 26.4 months.

AstraZeneca says that while overall survival data remain immature, early signals indicate a potential benefit with the Enhertu regimen. The combination “nearly doubled the number of patients showing no signs of disease on imaging,” the company adds. Principal investigator Sara Tolaney called the results “potentially practice-changing,” adding, “These data show Enhertu and pertuzumab could become the new first-line standard for HER2-positive metastatic breast cancer.”

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