eShowcase: Oracle Initiatives Focus on Drug Safety

New Phase III data published in The New England Journal of Medicine show elinzanetant, a nonhormonal dual NK-1/NK-3 receptor antagonist, significantly reduced vasomotor symptoms, improved sleep, and enhanced quality of life for women undergoing endocrine therapy for HR-positive breast cancer.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Primary results from the Phase II TRANSCEND FL trial show Breyanzi (lisocabtagene maraleucel) achieved a 95.5% response rate and durable efficacy in relapsed or refractory marginal zone lymphoma, supporting its potential as a transformative CAR T-cell therapy.

Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.

As wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous heart data while reducing patient burden.