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.
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