FDA Grants Priority Review To MM-398 in Pancreatic Cancer

Early endpoints are a balance of risk and benefit

Early endpoints have the potential to get effective drugs to patients faster, but granting approval to drugs—even accelerated approval—comes with the risk that ineffective or even harmful drugs will be given to patients.

October 29, 2025

Vol.51 No.39

Regulatory News

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.

October 24, 2025

Vol.51 No.39

By Jacquelyn Cobb

Duke brain cancer researcher Kyle Walsh named director of NIEHS

Kyle Walsh, a brain tumor expert at the Duke Cancer Institute, was named director of the National Institute of Environmental Health Sciences.

GRAIL to use new study results to seek FDA approval of Galleri MCD test

Recent results from the PATHFINDER 2 study showed that the addition of GRAIL’s multi-cancer detection test to standard screening led to a seven-fold increase in cancers detected within a year, the company said.

October 24, 2025

Vol.51 No.39

By Jacquelyn Cobb

Omar Abdel-Wahab, John Byrd, Lieping Chen, Robert Ferris, Wendy Garrett, Victor Velculescu are among new members of National Academy of Medicine

The National Academy of Medicine announced the election of 90 regular members and 10 international members during its annual meeting Oct. 18-20.

October 24, 2025

Vol.51 No.39

By Paul Goldberg

Clinical Trials & Tribulations

Experts warn that loss of carcinogen surveillance threatens to increase cancer incidence

Testing of chemicals for potential cancer causation (carcinogenesis) has long been a successful disease-prevention initiative of the highest priority.

October 24, 2025

Vol.51 No.39

By David M. DeMarini, Rosalie Elespuru, Miriam C. Poirier and Errol Zeiger

FDA Grants Priority Review To MM-398 in Pancreatic Cancer

YOU MAY BE INTERESTED IN

Early endpoints are a balance of risk and benefit

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

Duke brain cancer researcher Kyle Walsh named director of NIEHS

GRAIL to use new study results to seek FDA approval of Galleri MCD test

Omar Abdel-Wahab, John Byrd, Lieping Chen, Robert Ferris, Wendy Garrett, Victor Velculescu are among new members of National Academy of Medicine

Experts warn that loss of carcinogen surveillance threatens to increase cancer incidence

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FDA Grants Priority Review To MM-398 in Pancreatic Cancer

YOU MAY BE INTERESTED IN

Early endpoints are a balance of risk and benefit

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

Duke brain cancer researcher Kyle Walsh named director of NIEHS

GRAIL to use new study results to seek FDA approval of Galleri MCD test

Omar Abdel-Wahab, John Byrd, Lieping Chen, Robert Ferris, Wendy Garrett, Victor Velculescu are among new members of National Academy of Medicine

Experts warn that loss of carcinogen surveillance threatens to increase cancer incidence

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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