Biotech major Amgen (Nasdaq: AMGN) has announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for tarlatamab.
The investigational delta-like ligand 3 (DLL3) targeting bispecific t-cell engager (BiTE) therapy is in development for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
"The FDA's Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC"If approved, tarlatamab would be the first BiTE therapy for a major solid tumor. The FDA action date for a decision is June 12, 2024.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze