Certara 与迪哲强强联手助力舒沃替尼斩获FDA肺癌适应症加速批准

Dizal (Jiangsu) Pharmaceutical was developing Sunvozertinib (DZD9008), a selective EGFR tyrosine kinase inhibitor, to address a critical unmet need inpatients with metastatic NSCLC harboring EGFR exon20 insertion mutations.​

Existing treatments had limited benefit and high toxicity, making it vital to clearly demonstrate benefit-risk to regulators. To secure accelerated FDA approval, Dizal needed to:​

• Build a robust understanding of Sunvozertinib and its metabolite DZ0753.​
• Identify key sources of PK variability across diverse patients.​
• Define exposure–response (E-R) relationships for efficacy and safety.​
• Navigate complex global regulatory submissions under tight timelines.​

Dizal partnered with Certara to leverage expertise in pharmacometrics and regulatory strategy.​

Certara delivered comprehensive modeling and analysis, including:​

• Joint Population PK Model: Built a semi-mechanistic, two-compartment model describing the PK of Sunvozertinib and its metabolite DZ0753 across healthy volunteers and NSCLC patients.​
• Exposure–Response (E-R) Analysis: Linked sunvozertinib exposure to efficacy (objectiveresponse rate) and safety outcomes, including key adverse events such as diarrhea, rash, and dose-limiting toxicities.​
• Regulatory-Ready Deliverables: Provided validated reports and simulations quantifying variability across patient factors like age, bodyweight, and organ function to support global submissions.​

Through this collaboration, Dizal successfully:​

• Justified the benefit-risk profile of Sunvozertinib, supporting its selection as the optimal therapy for patients with EGFR exon20 insertion mutations.​
• Streamlined regulatory submissions with clear, validated population PK and E-R analyses.​
• Enabled data-driven dose selection for current and future studies, reducing the need for unnecessary clinical trials.​
• Achieved accelerated FDA approval, bringing a life-changing oral therapy to patients faster than traditional development timelines.