> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Fast Track for eFFECTOR’s Zotatifin
- URL: https://www.fdaweb.com/fda-fast-track-for-effectors-zotatifin/
- Published: 2023-11-30T12:00:00.000Z
- Updated: 2026-09-14T14:17:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155894

FDA has granted fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with fulvestrant and abemaciclib (ZFA triplet) to treat ER+/HER2- advanced metastatic breast cancer. The company [says](https://www.globenewswire.com/news-release/2023/11/28/2786889/0/en/eFFECTOR-Receives-U-S-FDA-Fast-Track-Designation-for-Zotatifin-in-Combination-with-Fulvestrant-and-Abemaciclib-for-Treatment-of-ER-HER2-Advanced-Metastatic-Breast-Cancer.html?ref=fdaweb.com) the designation covers the use of ZFA triplet for second- or third-line treatment of adult patients with disease progression following treatment with endocrine therapy and a CDK 4/6 inhibitor.

Zotatifin is described as a “potent and sequence-selective small molecule inhibitor of the RNA helicase eIF4A that is designed to suppress the expression of a network of cancer-driving proteins, including Cyclins D and E, CDKs 2, 4, and 6 and select RTKs as well as KRAS.” It is currently being evaluated in an ongoing clinical trial in patients with ER+/HER2- metastatic breast cancer.