Regulatory Challenges: Is a Surrogate End Point Instead of Overall Survival Enough for Regulatory Approval of (Neo)Adjuvant Cancer Treatment? The Swissmedic Perspective

J Clin Oncol. 2023 Nov 10;41(32):4973-4975. doi: 10.1200/JCO.23.01442. Epub 2023 Sep 21.

Authors

Matea Pavic¹, Anita Wolfer¹, Qiyu Li¹, Arunas Gircys¹, Stephanie Juritz¹, Andreas Wicki^{2

3}, Thomas Cerny³, Ulrich-Peter Rohr¹

Affiliations

¹ Division Clinical Assessment, Authorisation Sector, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland.
² Department of Medical Oncology and Hematology, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
³ Human Medicines Expert Committee (HMEC), Swissmedic, Bern, Switzerland.

PMID: 37733978
DOI: 10.1200/JCO.23.01442

No abstract available

MeSH terms

Adjuvants, Immunologic* / therapeutic use
Biomarkers
Humans
Neoadjuvant Therapy
Neoplasms* / drug therapy

Substances

Biomarkers
Adjuvants, Immunologic