Fast Track designation

January 7, 2021January 7, 2021

ARX788 on FDA Fast Track for Advanced HER2-positive Breast Cancers

News

ARX788 has been given a fast track designation by the U.S. Food and Drug Administration as a monotherapy for patients with HER2-positive metastatic breast cancer previously treated with at least ... Read more

October 8, 2020October 8, 2020

FDA Puts Eganelisib on Fast Track for Advanced Triple-negative Breast Cancer

News

The U.S. Food and Drug Administration has granted fast track status to immuno-oncology candidate eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy as a first-line treatment for patients with ... Read more

September 16, 2019

TNBC Patient Given Investigative Antibody, Leronlimab, Under Emergency Exception

News

A metastatic triple-negative breast cancer (TNBC) patient is being treated with CytoDyn’s investigational leronlimab (PRO 140) under an emergency investigational new drug (IND) application granted by the U.S. Food and ... Read more

April 20, 2018

FDA Grants Fast Track Status to Breast Cancer Therapy Candidate Balixafortide Combined with Halaven

News

The U.S. Food and Drug Administration granted fast track status to Polyphor’s immuno-oncology candidate balixafortide (POL6326) in combination with Halaven (eribulin mesylate) to treat a subset of patients with metastatic ... Read more

May 16, 2017May 16, 2017

Oncolytics’ Reolysin Receives FDA Fast Track Designation for Metastatic Breast Cancer

News

The U.S. Food and Drug Administration has granted fast track status to Reolysin for treating metastatic breast cancer, according to its developer, Oncolytics Biotech. Fast track accelerates the review of therapies ... Read more

April 13, 2017

Innocrin Names New CEO and Gets Fast-tracked by FDA for Breast Cancer Treatment Seviteronel

News

Innocrin Pharmaceuticals has named Fred Eshelman, PharmD, as its new CEO and learned it was granted a second fast track designation for seviteronel (VT-464) for the treatment of several types of ... Read more

December 12, 2016

FDA Grants Fast-track Status to New Antibody Therapy for HER2-Positive Advanced Breast Cancer

News

The U.S. Food and Drug Administration (FDA) has granted fast-track status to Daiichi Sankyo’s investigational therapy DS-8201a for patients with HER2-positive advanced breast cancer whose disease progressed after other HER2 therapies, such as ... Read more