Fast Track Designation

April 6, 2020April 6, 2020

ME-401 Put on FDA’s Fast Track for Previously Treated Follicular Lymphoma

News

The U.S. Food and Drug Administration (FDA) has granted fast track designation to MEI Pharma‘s investigational compound ME-401 for treating follicular lymphoma patients who received at least two prior therapies. A ... Read more

November 15, 2019

Nanatinostat Combo Put on FDA’s Fast Track for Hard-to-treat Lymphomas Linked to EBV Infection

News

The U.S. Food and Drug Administration has granted fast track designation to a combination of Viracta Therapeutics‘ investigational therapy nanatinostat and the antiviral valganciclovir in treating relapsed or refractory lymphomas ... Read more

November 14, 2019December 20, 2019

FDA Grants Fast Track Status to Triumvira’s T-cell Therapy TAC01-CD19 for DLBCL

News

The U.S. Food and Drug Administration (FDA) has granted fast track designation to Triumvira Immunulogics‘ investigational T-cell therapy TAC01-CD19 for the treatment of relapsed or refractory diffuse large B-cell lymphoma ... Read more

September 26, 2019

FDA Grants Abexinostat Fast Track Status for Follicular Lymphoma

News

Xynomic Pharmaceutical‘s abexinostat has received Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a fourth-line treatment for follicular lymphoma, the company announced in a press release. ... Read more

August 8, 2019September 10, 2019

FDA Asked to Place Abexinostat, Possible Follicular Lymphoma Treatment, on Fast Track

News

Xynomic Pharmaceuticals has filed a request with U.S. Food and Drug Administration (FDA) asking that abexinostat, its lead therapeutic candidate for relapsed or refractory follicular lymphoma, be given fast track designation. The ... Read more

July 16, 2019

FDA Grants Fast Track Status to Investigational Compound CLR 131 for DLBCL

News

Cellectar Biosciences’ investigational radiotherapeutic compound, CLR 131, has received fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory diffuse large B-cell ... Read more

November 20, 2018

Adcetris-Chemo Combo Gets FDA Approval for First-line Treatment of PTCL

News

The U.S. Food and Drug Administration (FDA) approved Seattle Genetics‘ application requesting that Adcetris (brentuximab vedotin) be used in combination with chemotherapy as a first-line treatment for systemic anaplastic large cell ... Read more

May 8, 2018

Forty Seven’s 5F9 Immunotherapy on FDA Fast Track for DLBCL, Follicular Lymphoma

News

The U.S. Food and Drug Administration has granted fast track status to Forty Seven’s lead candidate Hu5F9-G4 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma. ... Read more

December 18, 2017

Rhizen’s Tenalisib Receives FDA Fast Track Status for Peripheral T-cell Lymphoma

News

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the tenalisib (RP6530), Rhizen Pharmaceuticals‘ PI3K delta/gamma blocker, for the treatment of patients with relapsed or refractory peripheral ... Read more