Trial of tilsotolimod + ipilimumab in anti-PD-1 refractory advanced melanoma fails to meet ORR

FDA publishes draft guidance to accelerate biosimilar development and lower costs

In a new draft guidance, FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.

October 31, 2025

Drugs & Targets

EC approves Keytruda combination for a head-and-neck indication

The European Commission approved Keytruda (pembrolizumab), an anti-PD-1 therapy, as a monotherapy for the treatment of resectable locally advanced head-and-neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score ≥1.

October 31, 2025

Podcast

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

Trial of tilsotolimod + ipilimumab in anti-PD-1 refractory advanced melanoma fails to meet ORR

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FDA publishes draft guidance to accelerate biosimilar development and lower costs

EC approves Keytruda combination for a head-and-neck indication

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

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Trial of tilsotolimod + ipilimumab in anti-PD-1 refractory advanced melanoma fails to meet ORR

YOU MAY BE INTERESTED IN

FDA publishes draft guidance to accelerate biosimilar development and lower costs

EC approves Keytruda combination for a head-and-neck indication

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

Never miss an issue!

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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