FDA lifts pause on Seattle Genetics' drug trials

The Food and Drug Administration removed a clinical hold it placed on Seattle Genetics' drug trial in December following the deaths of four patients, reports Reuters.

During the trial for vadastuximab talirine — an experimental cancer drug — four acute myeloid leukemia patients died from liver toxicity.

The FDA paused the trial to evaluate the potential risk of liver toxicity in patients treated with the drug who underwent a stem cell transplant either before or after treatment.

Seattle Genetics on Monday said the clinical hold was resolved due to " a comprehensive analysis of the clinical data from over 300 patients treated to date, evaluation by an independent committee of clinical experts, collaborative interactions with the FDA and protocol amendments designed to further enhance patient safety," according to Jonathan Drachman, MD, the company's CMO and executive vice president of research and development.

The drugmaker plans to resume two early-stage trials and start a mid-stage trial of the drug in patients with acute myeloid leukemia in this year, according to the report.

More articles on supply chain:

Lawmakers seek to accelerate approvals with Reauthorized Generic Drug User Fee Act
Physician avoids high cost of EpiPens with homemade device
4 reasons supply chain managers could one day become CEOs

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars