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Cancer Drug Endpoints: ctDNA Promising But Presents Many Challenges, Experts Say

 
• By Sue Sutter

To validate change in circulating tumor DNA as an early endpoint predictive of longer-term outcomes, academia, industry and regulators must harmonize data collection for trials in early-stage disease, a Friends of Cancer Research white paper states.

Long road
The road to establishing ctDNA as predictive of long-term outcomes in early-stage disease is a long one. • Source: Alamy

Circulating tumor DNA potentially could serve as an early endpoint in cancer clinical trials, but academia, industry, regulators and the patient community will have to work together in overcoming numerous technical and clinical challenges to establish the biomarker’s utility in drug development, experts said.

In a white paper and panel discussion at the Friends of Cancer Research’s recent annual meeting, stakeholders highlighted the...

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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.

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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.