FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards
A little more than two months after the FDA put a clinical hold on early-stage work of its armed antibody dubbed SGN-CD33A (vadastuximab talirine) in acute myeloid leukemia following the deaths of 4 patients, the agency has come back to lift the hold and give Seattle Genetics the green light to continue.
Moving forward, the biotech says it’s implementing added risk mitigation measures in all vadastuximab talirine studies, including “revised eligibility criteria and stopping rules for veno-occlusive disease.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.