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Case Study

Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer

Dizal (Jiangsu) Pharmaceutical developed Sunvozertinib (DZD9008), a selective EGFR tyrosine kinase inhibitor, to treat metastatic NSCLC patients with EGFR exon 20 insertion mutations—an area with limited treatment options. To secure accelerated FDA approval, Dizal partnered with Certara to address PK variability, define exposure–response (E-R) relationships, and support global regulatory submissions under tight timelines.
Certara built a population PK model for Sunvozertinib and its metabolite, performed E-R analyses linking exposure to efficacy and safety, and delivered regulatory-ready reports. This collaboration streamlined submissions, informed dose selection, and helped achieve accelerated approval, bringing a needed oral therapy to patients faster.
Therapeutic area

Oncology

The challenge

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

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

  • Build a robust understanding of Sunvozertinib andits metabolite DZ0753.​
  • Identify key sources of PK variability acrossdiverse patients.​
  • Define exposure–response (E-R) relationships forefficacy and safety.​
  • Navigate complex global regulatory submissionsunder tight timelines.​

The solution

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

Certara delivered comprehensive modeling andanalysis, including:​

  • Joint Population PK Model: Built a semi-mechanistic, two-compartment modeldescribing the PK of Sunvozertinib and itsmetabolite DZ0753 across healthy volunteersand NSCLC patients.​
  • Exposure–Response (E-R) Analysis: Linkedsunvozertinib exposure to efficacy (objectiveresponse rate) and safety outcomes, includingkey adverse events such as diarrhea, rash, anddose-limiting toxicities.​
  • Regulatory-Ready Deliverables: Providedvalidated reports and simulations quantifyingvariability across patient factors like age, bodyweight, and organ function to support globalsubmissions.​

The impact

Through this collaboration, Dizal successfully:​

  • Justified the benefit-risk profile ofSunvozertinib, supporting its selection as theoptimal therapy for patients with EGFR exon20 insertion mutations.​
  • Streamlined regulatory submissions withclear, validated population PK and E-Ranalyses.​
  • Enabled data-driven dose selection forcurrent and future studies, reducing the needfor unnecessary clinical trials.​
  • Achieved accelerated FDA approval, bringing alife-changing oral therapy to patients fasterthan traditional development timelines.

“Sunvozertinib received accelerated FDA approval for metastatic NSCLC with EGFR exon 20 insertion mutations — a milestone achieved through exceptional collaboration.”

Kan Chen, Vice President of Clinical Pharmacology, Dizal (Jiangsu) Pharmaceutical

Contact Certara


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