BioNTech Reports the Lifting of Partial Clinical Hold for BNT326/YL202
Shots:
- Based on safety data from the ongoing study, BioNTech reported that the US FDA lifted the partial clinical hold on MediLink’s P-I accessing BNT326/YL202 in patients who have already received treatment for EGFR-mutated NSCLC and HR+/HER2- breast cancer
- The company updated the investigator brochure, informed consent documents for patients, and a revised clinical trial protocol, that satisfies the FDA's requirements by integrating additional risk mitigation measures
- Study recruitment will resume, targeting dose levels up to 3 mg/kg where safety is manageable and clinical activity is promising
Ref: BioNTech | Image: BioNTech
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