PI3K inhibitor hit with an increased death risk warning from FDA after final trial results emerge
The FDA sent a fresh warning on Thursday about Secura Bio’s embattled PI3K inhibitor Copiktra (duvelisib), which may increase the risk of death and severe side effects for patients as a third-line treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Copiktra won approval for both indications in 2018, but the FDA now says that after a median of 63 months follow-up in the Phase III that led to the approvals, the final overall survival results showed a possible increased risk of death for those taking Copiktra, with a hazard ratio of 1.09 (95% confidence interval [CI] 0.79, 1.51). In addition, 80/160 of those enrolled in the trial and on Copiktra ended up dying, compared with 70/159 of those on Novartis’ ofatumumab, FDA said.
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