Drugs

FDA Approves Enhertu for Some Additional Breast Cancers

FDA has approved Daiichi Sankyo’s Enhertu (fam-tastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant setting and have developed disease recurrence during or within six months of completing therapy. An agency announcement says Enhertu received 12/2019 accelerated approval for adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The following study was the confirmatory trial for the accelerated approval.

Efficacy for the new indication was based on DESTINY-Breast03, FDA says. The main efficacy outcome was progression-free survival, while overall survival and confirmed objective response rate were the key secondary outcome measures.

The labeling includes a Boxed Warning on the risk of interstitial lung disease and embryo-fetal toxicity.

FDA’s review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. For this review the agency collaborated with the Australian Health Goods Administration, Health Canada, Israel’s Ministry of Health Pharmaceutical Administration, and Switzerland’s Swissmedic.

The review used the Real-Time Oncology Review pilot program to streamline data submission before filing the entire clinical application, and the Assessment Aid voluntary submission. The application was granted FDA priority review, breakthrough designation, and orphan drug designation.

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