Drugs

Positive Data on New Breast Cancer Drug

BioNTech and Duality Biologics say their experimental antibody-drug conjugate, trastuzumab pamirtecan (BNT323/DB-1303), met its primary endpoint in a pivotal Phase 3 trial for patients with HER2-positive metastatic or unresectable breast cancer. The China-based study compared trastuzumab pamirtecan to the approved therapy trastuzumab emtansine (T-DM1) in patients previously treated with trastuzumab and taxane chemotherapy. They say an interim analysis showed the candidate extended progression-free survival, leading the trial’s independent data monitoring committee to confirm success on the trial’s main endpoint.

The therapy, developed using DualityBio’s DITAC platform, is a third-generation HER2-targeted ADC linked to a topoisomerase-1 inhibitor payload, according to the companies. Early data suggested activity across both HER2-positive and HER2-low cancers, as well as other solid tumors such as endometrial cancer, they say, adding that the development program has previously received fast track and breakthrough therapy designations from FDA.

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