Can ctDNA be used as an endpoint for cancer drug development? Friends collaboration to present initial results July 11

Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLC
ctMoniTR project aims to improve efficiency in development of intermediate endpoints

New research led by Friends of Cancer Research demonstrates that decreases in circulating tumor DNA after initiation of treatment are associated with improved overall survival in patients with advanced non-small cell lung cancer treated with immunotherapy or chemotherapy.

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Earlier this year, FDA announced that it would be initiating a voucher program aimed at accelerating review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, June 20, 2025).

October 24, 2025

Vol.51 No.39

By Claire Marie Porter

Clinical Regulatory News Trials & Tribulations

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL).

October 17, 2025

Vol.51 No.38

By Edison T. Liu

News Analysis Regulatory News

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Bowing to the growing animal rights movement, FDA and NIH have made policy changes to discourage animal testing, instead favoring alternative research models.

October 17, 2025

Vol.51 No.38

By Claire Marie Porter and Jacquelyn Cobb

Why both somatic and germline genomic profiling are essential for precision oncology

Over the past three decades, cancer genetics has transformed precision oncology. Germline testing has advanced from single-gene Sanger sequencing to parallel sequencing of hundreds of genes, while tumor (somatic) testing has expanded with the rise of targeted therapies based on point mutations, copy number changes and other alterations.

October 17, 2025

Vol.51 No.38

By Heather Hampel and David W. Craig

Drugs & Targets

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

FDA has received reports of immune effector cell-associated enterocolitis in patients who received treatment with Carvykti.

October 17, 2025

Vol.51 No.38

Can ctDNA be used as an endpoint for cancer drug development?

Friends collaboration to present initial results July 11

YOU MAY BE INTERESTED IN

Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLC
ctMoniTR project aims to improve efficiency in development of intermediate endpoints

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Why both somatic and germline genomic profiling are essential for precision oncology

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

Renew today!

Subscriber content

Never miss an issue!

Login

Can ctDNA be used as an endpoint for cancer drug development?

Friends collaboration to present initial results July 11

YOU MAY BE INTERESTED IN

Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLCctMoniTR project aims to improve efficiency in development of intermediate endpoints

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issueWhile cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Why both somatic and germline genomic profiling are essential for precision oncology

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

Never miss an issue!

Login

Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLC
ctMoniTR project aims to improve efficiency in development of intermediate endpoints

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough