In December of last year, the FDA ordered three early clinical trials of one of Seattle Genetics’ cancer drugs put on hold.
This morning, the company announced that hold has been lifted and that two of the three trials will continue as planned. The company’s stock did not react noticeably to the news, dipping about 1 percent to $67.75 over the course of the morning.
The drug, known as vadastuximab talirine or SGN-CD33A, is being studied in patients with acute myeloid leukemia (AML).
The FDA ordered one preclinical trial of the drug placed on a full hold and two phase 1 trials of the drug put on a partial hold, meaning patients already enrolled could continue treatments. Those holds followed six cases of drug-induced liver damage among the 300 patients enrolled in various trials of the drug. Four patients died from the liver damage.
During the hold, the FDA and Seattle Genetics conducted an investigation to find out if the drug could be the cause of those cases. Although the investigation’s findings were not released today, the FDA lifted its hold and Seattle Genetics said its two phase 1 trials will proceed as planned.
“The clinical hold on our early-stage vadastuximab talirine clinical trials has been resolved through 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,” Jonathan Drachman, Seattle Genetics’ Chief Medical Officer and EVP of Research and Development, said in a statement.
Drachman also said the third trial would be discontinued because of the difficulty of developing therapies in the specific treatment area the trial was addressing.
One trial of the drug is already in the final stages of clinical testing and was not put on hold. Another preclinical trial was also allowed to continue.