Work

133P Regulatory divergence in EMA approvals for targeted therapies in oncogene addicted NSCLC

Year: 2026

Type: article

Abstract: CHMP decisions for biomarker-defined NSCLC therapies have shown some variability in approval type (conditional vs. full), the scope of the indication (line-agnostic vs. setting-specific) and in the evidence required for regulatory decision-making. Investigation of the factors behind divergent regulatory outcomes could help clarify the regulatory pathway for future drugs targeting molecularly-defined subsets of NSCLC.

Source: ESMO Open

DOI: 10.1016/j.esmoop.2026.106275

Authors: A.E. Sosa Mejia, B. Haddock Lobo Goulart, L. Fashoyin-Aje, S.B. Sarac

Institutions: PAREXEL International (United Kingdom), PAREXEL International (United States)

Language: English

Topic: Lung Cancer Treatments and Mutations

Subfield: Pulmonary and Respiratory Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,910