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Secura’s Copiktra: Trial Design, Shifting Standard Of Care Could Spell The End For Third-Line CLL/SLL

 
• By Sue Sutter

In concluding benefits do not outweigh risks in the drug’s current indication, US FDA advisory committee members cite concerns about survival data from the Phase III DUO trial, as well as the drug’s toxicities, safety issues with the PI3K inhibitor class, and the changing treatment landscape for chronic lymphocytic leukemia and small lymphocytic lymphoma.

Changing landscape
The changing therapeutic landscape in CLL/SLL has influenced the FDA's reconsideration of Copiktra's benefit-risk profile. • Source: Shutterstock

The benefit-risk profile for Secura Bio, Inc.’s Copiktra (duvelisib) is not favorable in its current indication for third-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), a US Food and Drug Administration advisory committee said on 23 September.

In voting 8-4 that the drug’s benefits do not outweigh its risks, Oncologic Drugs Advisory Committee members in the majority...

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More from US FDA Performance Tracker

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

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America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Global Pharma Guidance Tracker - May 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.