A Win for AI in Cancer; 2025’s Transformative Drugs; FDA Clarifies ‘Underway’ Trials

An artificial intelligence (AI) system used in a nationwide breast cancer screening program increased cancer detection with breast CT and mammography. (The Guardian)

An AI system developed to predict a patient’s response to immunotherapy could help “democratize” access to the pricey drugs for cancer treatment. (Mount Sinai, Memorial Sloan Kettering Cancer Center)

Medical publishing giant Elsevier denied using AI in the production process for the Journal of Human Evolution, as former editorial board members alleged in a statement following their resignation. (Retraction Watch)

Peter Yarrow, 86 — of the iconic folk-music group Peter, Paul and Mary — died earlier this week, 4 years after a bladder cancer diagnosis. (People)

Event-free survival in high-risk non-muscle invasive bladder cancer improved significantly with the addition of the subcutaneously administered PD-1 inhibitor sasanlimab to standard bacille Calmette-Guérin therapy, Pfizer announced.

Three cancer agents — tarlatamab (Imdelltra), vepdegestrant, and zanzalintinib — made a list of 11 drugs that have “transformative” potential for medicine in 2025. (Clarivate)

A phase I study showing “meaningful” improvement in survival with a CAR T-cell therapy for pediatric diffuse intrinsic pontine glioma has set the stage for a phase II clinical trial, BrainChild Bio announced.

A subcutaneous formulation of isatuximab (Sarclisa SC) — added to pomalidomide (Pomalyst) and dexamethasone for relapsed/refractory multiple myeloma — met co-primary endpoints of non-inferior response rate and drug concentration before dosing as compared with intravenous isatuximab, Sanofi announced.

Responding to criticisms about recent accelerated approval withdrawals and delayed confirmatory trials, the FDA issued new guidance clarifying its definition of “underway” for confirmatory studies.

The agency also issued draft guidance for use of tissue biopsies in clinical trials.

The Head and Neck Radiation Oncology Group (GORTEC) announced significant improvement in disease-free survival for locally advanced squamous cell carcinoma of the head and neck with the addition of nivolumab (Opdivo) to standard-of-care radiation therapy and cisplatin.

Overall survival in locally advanced/metastatic EGFR-mutated non-small cell lung cancer improved significantly with first-line amivantamab (Rybrevant) and lazertinib (Lazcluze) versus osimertinib (Tagrisso), Johnson & Johnson announced.

A novel technology that simulates normal cell differentiation could lead to a type of cancer therapy that transforms cancer cells into normal cells instead of killing them. (Advanced Science)

Using gene-editing technology to study 7,000 variants of BRCA2 provided new insights into how the gene causes cancer and could potentially improve cancer screening, prevention, and treatment. (Mayo Clinic)