Drugs

Xtandi Wins on Overall Survival in PROSPER Trial

Pfizer and Astellas Pharma report that the Phase 3 PROSPER trial demonstrated a statistically significant improvement in overall survival (OS) in men with non-metastatic castration-resistant prostate cancer who were treated with Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT. OS was a key secondary endpoint in the trial. In 2018, the companies announced that the PROSPER trial met its primary endpoint of metastasis-free survival (MFS). In a preliminary analysis, adverse events were generally consistent with those previously reported from PROSPER, the companies say. Detailed efficacy and safety results from the final analysis will be shared at a later date.

Xtandi is an androgen receptor inhibitor indicated for treating patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. PROSPER efficacy and safety data at the time of the MFS analysis are included in the XTANDI labels in the U.S., Europe and Japan.

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