Research Triangle Park, NC — The Oncologic Drugs Advisory Committee to the FDA voted overwhelmingly yesterday that the risk-benefit assessment for PD-L1 inhibitors in first-line, HER2-negative gastric cancer and first-line advanced esophageal squamous cell carcinoma is not favorable in patients with PD-L1 expression <1.

Ahead of this meeting, TruLab submitted a statement in support of keeping broad approvals for these patient populations, regardless of individual biomarker expression. As many experts also presented yesterday, significant variance in tumor tissue collection and processing methods across institutions nationwide leads to inconsistent and often unreliable results.

With accurate biomarker testing hinging on the highest quality tumor tissue samples, limiting access to life-saving therapies before robust standards for sample handling and data collection are in place is premature and will heap significant additional burden on patients.

Read our full statement at Regulations.gov.

About TruLab

Founded in 2018, TruLab is now the leading provider of technology for clinical trial oversight, dedicated to enhancing data quality, and mitigating risks in drug development. TruLab currently supports four top pharmaceutical companies as well as numerous biotechnology companies to speed patient screening and enrollment, ensure data integrity, and prevent protocol deviations.