Drugs

Datroway Positive Data in Breast Cancer Patients

AstraZeneca and Daiichi Sankyo say new data show that their antibody-drug conjugate Datroway (datopotamab deruxtecan) significantly improved survival outcomes for patients with metastatic triple-negative breast cancer who are not eligible for immunotherapy. Results from the Phase 3 TROPION-Breast02 trial also showed the therapy met its second co-primary endpoint of progression-free survival.

The drug is currently approved for treating hormone receptor–positive, HER2-negative breast cancer, and has also received accelerated approval for EGFR-mutated non-small cell lung cancer.

The companies characterized the trial results as “the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option. These results may mark an inflection point in the treatment of these patients, who urgently need better options.”

Datroway’s safety profile was consistent with previous studies, and detailed efficacy and safety data will be presented at an upcoming medical meeting, the companies say. Data will also be submitted to FDA and other regulatory agencies for a potential label expansion.

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