Tagged News
UroLift System Demonstrates Superior Patient Outcomes in Head-to-Head BPH Treatment Trials
• New clinical data presented at the 2025 AUA Annual Meeting shows the UroLift System provides better early patient satisfaction and faster symptom relief compared to Rezūm and tamsulosin for BPH treatment.
• Two randomized controlled trials revealed UroLift patients experienced shorter catheterization times, better sexual function outcomes, and higher overall satisfaction during early recovery periods.
• Real-world data from the American Urological Association Quality Registry confirms UroLift provides rapid symptom improvement at three months, reinforcing its position as a leading minimally invasive BPH treatment option.
The Rising Importance of Real-World Data and Evidence in Pharmaceutical R&D
• Real-World Data (RWD) and Real-World Evidence (RWE) are transforming pharmaceutical R&D by complementing traditional randomized clinical trials with data collected from routine healthcare settings.
• Regulatory agencies worldwide, including the FDA and EMA, are increasingly accepting RWE for drug approvals, label expansions, and post-marketing surveillance, potentially accelerating patient access to treatments.
• RWE offers advantages including larger sample sizes, greater external validity, and insights into real-world effectiveness, though challenges remain in data quality, standardization, and privacy protection.
Lorlatinib Shows Promising Efficacy in ALK-Rearranged NSCLC with 21.8 Month Median PFS
• A real-world study of lorlatinib in ALK-rearranged non-small cell lung cancer demonstrated a median progression-free survival of 21.8 months, significantly higher than in previous trials.
• The objective response rate was 43% with disease control achieved in 94% of patients, while 81% of patients with brain metastases showed objective response for intracranial lesions.
• Patients experiencing adverse events, particularly hypercholesterolemia and edema, had significantly better outcomes than those without side effects, suggesting a potential correlation between drug exposure and efficacy.