Clinical Trial News

A recent analysis has sparked controversy over the FDA's accelerated approval of pembrolizumab for treating solid tumors with a high tumor mutational burden (TMB), citing concerns over the broadness of the approval criteria and the neglect of survival data in certain tumor types. The approval was based on the KEYNOTE-158 study, which showed a 29% overall response rate in patients with TMB greater than 10 mutations per megabase, but critics argue it overlooks more meaningful clinical endpoints like survival and quality of life.

PSMA-PET imaging, particularly with 68Ga-PSMA-11, is effective for detecting prostate cancer at low PSA levels. PSMA-targeted radionuclide therapy (TRT) using 131I-MIP-1095 and 177Lu-PSMA-617 shows promise in treating metastatic castration-resistant prostate cancer (mCRPC), with significant PSA declines observed. However, challenges include toxicity and the need for personalized dosing. Ongoing trials aim to optimize dosing and compare 177Lu-PSMA-617 with standard treatments, with VISION and TheraP studies highlighting its potential benefits over chemotherapy.

FDA mandates a Guillain-Barré Syndrome (GBS) warning for Shingrix, following postmarketing studies showing an increased GBS risk within 42 days post-vaccination. Evidence suggests an association, not causation, with 3-6 excess GBS cases per million doses in adults over 65. Benefits of Shingrix still outweigh risks.

A recent study applied the PRECISION biopsy strategy to a contemporary cohort, showing its effectiveness in reducing unnecessary biopsies and detecting clinically significant prostate cancer, while also identifying characteristics of missed cancers.

FDA granted breakthrough device status to several cardiovascular disease treatments, including Puzzle Medical Devices' ModulHeart pump, Alleviant Medical's implant-free heart failure treatment, Vascular Perfusion Solutions' cardiac transport device, and Pedra Technology's tissue perfusion system. Roche also received status for its Elecsys GDF-15 assay, and ShiraTronics and Geistlich Pharma for migraine treatment and cartilage repair, respectively.

The FDA has approved prucalopride (Motegrity) for treating chronic idiopathic constipation (CIC), offering a new treatment option that enhances colonic peristalsis to increase bowel motility. This approval is based on clinical studies showing significant improvements in patients.

Medtronic plc received FDA approval for the DiamondTemp™ Ablation (DTA) system, a temperature-controlled, irrigated RF ablation system for treating recurrent, symptomatic paroxysmal atrial fibrillation (AF) unresponsive to drug therapy. The DTA system, featuring industrial-grade diamonds for enhanced thermal conductivity, offers procedural efficiencies and safety. The DIAMOND-AF trial demonstrated its effectiveness and safety, with significant procedural advantages over conventional systems.

From 2000 to 2021, the US saw a significant increase in primary liver cancer cases and deaths, primarily due to Alcohol-Associated Liver Disease (ALD) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

Alleviant Medical Inc. received FDA Breakthrough Device designation for its no-implant transcatheter technology, aimed at treating heart failure patients with preserved or midrange ejection fraction. The technology creates a therapeutic interatrial shunt to reduce left atrial pressure without a permanent implant, currently under investigational use.

A comprehensive analysis of 5-year outcomes from the CheckMate 017 and 057 trials demonstrates that nivolumab significantly improves overall survival and progression-free survival rates compared to docetaxel in patients with previously treated, advanced non-small-cell lung cancer (NSCLC). The study highlights the long-term survival benefits and durable responses with nivolumab, alongside a favorable safety profile.