Drugs

AstraZeneca's Truqap for Prostate Cancer Approved

FDA has approved AstraZeneca's AKT inhibitor Truqap (capivasertib) in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, expanding the drug's reach into an earlier-stage prostate cancer setting and marking the first biomarker-directed approval for this patient population.

Alongside the drug approval, the agency cleared the Ventana PTEN (SP218) RxDx Assay from Roche's Ventana unit as a companion diagnostic to identify eligible patients.

The decision broadens Truqap's oncology footprint beyond breast cancer and provides AstraZeneca with a new precision medicine option in prostate cancer, where PTEN loss is among the most common genomic alterations and has been associated with aggressive disease and poorer outcomes, according to an FDA release.

FDA's approval was based on results from the Phase 3 CAPItello-281 study, which enrolled 1,012 patients with newly diagnosed PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. Patients were randomized to receive either capivasertib plus abiraterone and prednisone or abiraterone and prednisone alone.

The study met its primary endpoint of radiographic progression-free survival, FDA says. Patients receiving the Truqap-based regimen achieved a median radiographic progression-free survival of 33.2 months compared with 25.7 months for patients receiving placebo plus abiraterone, representing a 19% reduction in the risk of disease progression or death.

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

Read more

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