US Food and Drug Administration regulatory updates in neuro-oncology.

ABSTRACT:

Objective

Contemporary management of patients with neuro-oncologic disease requires an understanding of approvals by the US Food and Drug Administration (FDA) related to nervous system tumors. To summarize FDA updates applicable to neuro-oncology practitioners, we sought to review oncology product approvals and Guidances that were pertinent to the field in the past year.

Methods

Oncology product approvals between January 1, 2020, and December 31, 2020, were reviewed for clinical trial outcomes involving tumors of the nervous system. FDA Guidances relevant to neuro-oncology were also reviewed.

Results

Five oncology product approvals described outcomes for nervous system tumors in the year 2020. These included the first regulatory approval for neurofibromatosis type 1:

SUBMITTER: Mehta GU 

PROVIDER: S-EPMC8218275 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature