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Evolution, Not Revolution, Marks Progress In Targeted Oncology Therapy – AACR

 
• By Bridget Silverman

The American Association for Cancer Research’s second annual Cancer Progress Report makes the case that oncology progression is more a process of refinement than breakthrough right now.

Though targeted oncology is still a booming sector, growth in the field is being driven less by revolutionary new approaches than by evolutionary or incremental improvements in targeting, sequencing and combining the new cancer drugs, according to a new report by the American Association for Cancer Research. But those gains are helping to shrink development and FDA review times in oncology.

Oncology drugs are currently experiencing a boom in approvals. In the first nine months of 2012, FDA approved 12 new molecular entities and novel biologic entities for cancer patients out...

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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.