Drugs

FDA OKs Enhertu Combo as First-Line for Advanced Breast Cancer

FDA has approved Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentech’s pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, expanding treatment options for patients with advanced disease. The approval covers patients whose tumors are HER2-positive — defined as immunohistochemistry 3+ or in situ hybridization+ — as determined by an FDA-approved test.

The decision is based on data from the Phase 3 DESTINY-Breast09 trial, a randomized, three-arm, global study involving 1,157 adults with advanced or metastatic HER2-positive breast cancer who had not previously received chemotherapy or HER2-targeted therapy for metastatic disease, or whose prior adjuvant or neoadjuvant HER2 therapy occurred more than six months earlier, according to an FDA release. Patients were assigned to receive Enhertu plus pertuzumab, a standard regimen of taxane chemotherapy with trastuzumab and pertuzumab (THP), or an investigational therapy.

Patients treated with the Enhertu–pertuzumab combination demonstrated a statistically significant improvement in progression-free survival compared with those receiving THP, FDA says. Median progression-free survival reached 40.7 months in the Enhertu combination arm, versus 26.9 months in the THP arm, representing a 44% reduction in the risk of disease progression or death. Confirmed objective response rates were also higher with the Enhertu combination, at 87%, compared with 81% for the standard regimen.

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