Drugs

Fast Track for Alessa’s Prostate Cancer Therapy

FDA has granted Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy. The designation applies to Enolen’s use in patients with low to intermediate risk, localized prostate cancer, a population for whom treatment options are often limited to active surveillance or more aggressive interventions associated with significant side effects.

The company described Enolen as a drug-eluting implant designed to deliver the anti-androgen therapy enzalutamide directly to prostate tissue. Enzalutamide is already approved as a systemic treatment for advanced prostate cancer, but Alessa’s approach aims to localize drug exposure to the prostate in order to limit the systemic side effects commonly associated with hormone-based therapies, such as sexual dysfunction, muscle loss, metabolic complications, and cardiovascular risks, according to the company.

Enolen is currently being evaluated in a Phase 1 clinical trial assessing safety, tolerability, and preliminary efficacy of sustained, localized delivery of enzalutamide in patients with localized prostate cancer. Alessa says it expects to report initial findings from the study later this year.

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