1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Tissue-Agnostic Approach To Cancer Drug Development Takes A Hit

 
• By Bridget Silverman

Roche's VE-BASKET trial based treatment on biomarkers instead of the tissue of origin, but it ended up reinforcing the importance of conventional tumor histology in drug development as a complement to new molecularly targeted approaches. Now, eyes are on Novartis' ambitious SIGNATURE program to confirm the signal-finding potential of the basket trial approach.

The first tests of a new genomically driven drug development model show that precision medicine must complement, not replace, the conventional paradigm of looking at cancer by anatomical site, according to molecular oncology powerhouse Roche.

Oncology has been transformed by targeted therapy based on molecular pathways, and the rapid spread of rapidly improving sequencing technology promises an avalanche of new genomic information – data that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

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.

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.