Estimation of Percentage of Patients With Fibroblast Growth Factor Receptor Alterations Eligible for Off-label Use of Erdafitinib.

ABSTRACT:

Importance

When a novel drug is granted accelerated approval, both its on-label and off-label uses must be taken into account.

Objectives

To estimate the potential upper bound of off-label use of erdafitinib to treat advanced cancer with fibroblast growth factor receptor gene (FGFR) alterations, compare it to the upper bound of on-label use in urothelial cancer, and to review studies that may support off-label use.

Design, setting, and participants

This cross-sectional study used frequency data on FGFR alterations by cancer type and the estimated number of deaths from all cancers for 2019 in the United States. Mortality statistics were used as surrogates for patients with advanced cancer. Analysis was conducted in May 2019.

Exposure

Percentage of patients with

SUBMITTER: de Almeida Carvalho LM 

PROVIDER: S-EPMC6902826 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature