Strategies for Evaluating NSCLC Therapies Granted FDA Accelerated Approval

EP: 1.Value of Comprehensive Molecular Testing in NSCLC

EP: 2.Unmet Needs in HER2-Mutant NSCLC

EP: 3.Treatment of HER2-Mutant NSCLC: Consequences of Delays and Strategies to Improve Timely Initiation

EP: 4.Overview of HER2-Targeted Therapies in NSCLC

EP: 5.Mechanistic Role of Emerging Tyrosine Kinase Inhibitors (TKIs) in HER2-Mutant NSCLC

EP: 6.Efficacy and Safety of Zongertinib in Previously Treated and Treatment-Naïve HER2-Mutant NSCLC from Beamion LUNG-1 Trial

EP: 7.Evaluating TKI Efficacy and Safety in HER2-Mutant NSCLC from SOHO-01 Trial

EP: 8.Safety Considerations and Patient-Reported Outcomes of TKIs in HER2-Mutant NSCLC

EP: 9.Opportunities for Positioning TKIs as First-Line Therapy in HER2-Mutant NSCLC

EP: 10.Additional Emerging HER2-Targeted Therapies in NSCLC

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EP: 11.Strategies for Evaluating NSCLC Therapies Granted FDA Accelerated Approval

EP: 12.Addressing Access Barriers for HER2-Targeted Therapies in NSCLC

This episode focuses on the strategies for assessing non-small cell lung cancer (NSCLC) therapies that have received FDA accelerated approval. The discussion explains that accelerated approval relies on surrogate endpoints, such as overall response rate, to expedite access to promising treatments while confirmatory phase 3 trials are still underway. Panelists highlight the necessary balance between early access to new therapies and the requirement for rigorous follow-up studies to confirm clinical benefit, noting that approvals can be withdrawn if subsequent trials do not verify effectiveness. The benefits of early access are discussed, particularly for patients who cannot enroll in clinical trials, along with the importance of clearly communicating to patients and stakeholders that ongoing evidence collection is required. The panel also reviews the significance of various clinical trial endpoints—including overall survival, progression-free survival, response rate, and patient-reported outcomes—in evaluating the true impact and value of therapies approved through the accelerated pathway.