Drugs

Daiichi Sankyo Speeding Breast Cancer BLA

Daiichi Sankyo says it is accelerating filing a BLA for [fam-] trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate in patients with HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (Genentech’s Kadcyla). The company says submission had been scheduled for 2020 but is now set for the first half of fiscal year 2019. FDA has granted the drug breakthrough therapy designation for treating patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab (Genentech’s Perjeta) and have disease progression after Kadcyla. The company says the BLA is based on results from the pivotal Phase 2 DESTINY-Breast01 study. Enrollment in the study was completed 9/2018 with about 230 patients at more than 100 sites around the world, Daiichi says.

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