Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs.

ABSTRACT:

Background

We examined how often new serious safety signals were identified by the U.S. Food and Drug Administration within the first 2 years after approval for new molecular entities (NMEs) for treatment of cancer that required specific regulatory actions described here.

Methods

We identified, for all NMEs approved for treatment of cancer or malignant hematology indications between 2010 and 2016, substantial safety-related changes within the first 2 years after approval, which included a new Boxed Warning or Warning and Precaution; requirement for (or modification of existing) Risk Evaluation and Mitigation Strategies (REMS); and withdrawal from the market because of safety concerns.

Results

Fifty-five NMEs were approved between 2010 and 2016: 32 (58%) under regular

SUBMITTER: Kim J 

PROVIDER: S-EPMC7160417 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature