Drugs

Promising Enhertu+Perjeta Data in Breast Cancer

AstraZeneca and Daiichi Sankyo are announcing interim data from the Phase 3 DESTINY-Breast09 trial that showed Enhertu (trastuzumab deruxtecan), in combination with Perjeta pertuzumab, significantly extended progression-free survival (PFS) compared to the current first-line standard of care (taxane, trastuzumab, and pertuzumab (THP)) in HER2-positive metastatic breast cancer patients.

The companies also note that the trial data showed that the Enhertu-pertuzumab combination achieved a highly statistically significant and clinically meaningful improvement in PFS across all pre-specified patient subgroups. While overall survival (OS) data remain “immature,” early trends suggest a potential benefit favoring the combination, they say.

“This is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic breast cancer population compared to the current 1st-line standard of care,” says AstraZeneca oncology executive vice president Susan Galbraith in a news release. “These results suggest that initiating treatment with Enhertu plus pertuzumab at the time of metastatic diagnosis may delay disease progression and extend the time before additional treatments are needed,” adds Daiichi Sankyo R&D head Ken Takeshita.

The companies say full data from the DESTINY-Breast09 combination arm will be presented at an upcoming medical conference and submitted to regulatory agencies.

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