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US FDA Panel To Weigh Whether Copiktra’s Benefit-Risk Profile In Hematologic Cancers Has Changed

 
• By Sue Sutter

Adverse trend in overall survival, tolerability concerns, and uncertainty regarding the dose suggest the PI3K inhibitor's benefit-risk profile in its current indications is unfavorable, FDA says. Secura Bio asserts OS data are confounded and safety issues are the same as at initial approval.

Risk outweighs benefit
FDA thinks the risks of Copiktra may now outweigh the drug's benefits in two hematologic malignancies. • Source: Shutterstock

An adverse trend in five-year overall survival, toxicity and tolerability concerns, and uncertainty regarding the selected dose suggest the benefit-risk profile of Secura Bio, Inc.’s Copiktra (duvelisib) in its current hematologic cancer indications is unfavorable, the US Food and Drug Administration said.

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