Drugs

FDA OKs AstraZeneca Breast Cancer Drug

FDA has approved an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test (FoundationOne CDx assay). The drug is intended for use following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy, an FDA release says.

Approval was based on data from the CAPItello-291 (NCT04305496) placebo-controlled, multicenter trial in 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer. In the study, 289 patients had tumors with PIK3CA/AKT1/PTEN-alterations, and the major efficacy outcome measure was investigator-assessed progression-free survival (PFS), FDA says. “In the 289 patients with PIK3CA/AKT1/PTEN-altered tumors, the median PFS was 7.3 months (95% CI: 5.5, 9.0) in the capivasertib-fulvestrant group and 3.1 months (95% CI: 2.0, 3.7) in the placebo-fulvestrant group (Hazard Ratio [HR] 0.50 [95% CI: 0.38, 0.65] p-value< 0.0001),” it says.

Regarding safety, the most common adverse reactions that were reported in 20% or more patients included diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting and stomatitis.

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