Biologics

sBLA for Enhertu in High-Risk Early Breast Cancer

FDA has accepted for review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) use followed by paclitaxel, trastuzumab, and pertuzumab (THP) as a neoadjuvant treatment for patients with high-risk, early-stage HER2-positive breast cancer. The agency has set a user fee review action target date of 5/18.

The submission is based on data from the Phase 3 DESTINY-Breast11 trial, which showed that the Enhertu regimen significantly improved pathologic complete response rates and had a more favorable safety profile compared to the standard dose-dense doxorubicin and cyclophosphamide followed by THP regimen, the companies say. An early trend toward improved event-free survival was also observed, they add.

In the DESTINY-Breast11 study, the safety profile of ENHERTU followed by THP was consistent with known data, with no new safety signals reported, according to the companies. Rates of interstitial lung disease were similar across treatment arms.

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