Two clinical trials have been paused within the past two days because six participants – including one child – have died, according to reports by the drug companies.
The two trials were unrelated: They were in different stages and testing therapies. But both were testing new cancer treatments. One was testing a treatment for a blood cancer called acute myeloid leukemia, or AML, and the other was testing a new agent for ovarian cancer. Deaths in clinical trials are thought to be rare.
“The safety of every patient who participates in our studies or is treated with our therapies is the utmost priority for us, and we are in communication with FDA while we assess the data surrounding this SAE [serious adverse event], and the potential next steps for the study,” said Dr. Steve Bernstein, chief medical officer 2seventy bio, in a news release. The second study, on ovarian cancer, was in phase three – typically the final stage before a company presents a drug for FDA approval.
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