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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...

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More from Clinical Trials

US FDA Plan To Limit Studies Eligible For Pediatric Exclusivity Criticized By Industry, NORD

 
• By Sue Sutter

The agency’s proposal to award six-month pediatric exclusivity only for studies beyond those required under the Pediatric Research Equity Act will weaken the incentive and result in less research for pediatric uses, stakeholders said.

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Germany: Newly Adopted Contractual Clauses To Reshape Clinical Trial Negotiations

 
• By Neena Brizmohun

Newly enacted standard contractual clauses for negotiating clinical trial agreements in Germany appear positive for sponsors compared to the clauses that trial sites were typically requesting in the past, eg, those relating to compensation for the transfer of inventions, according to lawyers.

Better, Faster, Quicker: EUCOPE’s Natz Urges EU Drug Regulators To Act Now – Not Wait For New Laws

 
• By Eliza Slawther

While the EU has many pieces of promising legislation in development, regulatory agencies should also prioritize making improvements within the existing framework rather than waiting for the new laws to take effect, EUCOPE secretary Alexander Natz says.

More from R&D

Better, Faster, Quicker: EUCOPE’s Natz Urges EU Drug Regulators To Act Now – Not Wait For New Laws

 
• By Eliza Slawther

While the EU has many pieces of promising legislation in development, regulatory agencies should also prioritize making improvements within the existing framework rather than waiting for the new laws to take effect, EUCOPE secretary Alexander Natz says.

Rese-Cel CAR T Therapy Secures EMA PRIME Designation

 
• By Neena Brizmohun

Cabaletta’s rese-cel is among the latest investigational drugs that have won a place on the European Medicines Agency priority medicines scheme. Meanwhile, 11 products were denied PRIME designations.

OMUFA Reauthorization: US FDA Would Identify Rx-OTC Switch Candidates, Work With Sponsors

 
• By Kate Rawson

The Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.