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Venclexta Out Of The Starting Gate With Approval In High-Risk CLL Subset

 
• By Emily Hayes

Roche/Abbvie’s first-in-class breakthrough BCL-2 inhibitor granted accelerated approval by FDA in relapsed CLL with 17p deletion.

Accelerated approval of Roche/AbbVie Inc.’s Venclexta (venetoclax) in chronic lymphocytic leukemia with the 17p deletion mutation is just the beginning for a drug that has demonstrated impressive response rates and is being positioned for a range of blood cancers.

Venetoclax (previously known as ABT-199) targets the protein B-cell lymphoma 2 (BCL-2), which is often over-expressed in CLL and is associated with cancer resistance.

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More from Clinical Trials

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

More from R&D

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.