Cancer News Roundup - August 27, 2025

BOSTON - The U.S. Food and Drug Administration (FDA) today confirmed a target action date of August 27, 2025, for its decision on the biologics license application (BLA) for TLX250-CDx, a novel imaging agent designed to improve detection of clear cell renal cell carcinoma (ccRCC). The priority review stems from results of the Phase 3 ZIRCON trial, which demonstrated 86% sensitivity and 87% specificity for TLX250-CDx PET/CT imaging in ccRCC patients, with a positive predictive value of 93%. In a subgroup of patients with small renal masses (≤4 cm), the agent showed sensitivity of 83.5% (95% CI, 74.6%-89.8%) and specificity of 90.7% (95% CI, 80.1%-96.0%). Telix Pharmaceuticals’ chief executive noted that approval would “revolutionize the management of kidney cancer” by providing more definitive diagnoses and guiding timely treatment decisions.

NEW YORK - A report published in JAMA Oncology today highlights the success of the Breast Cancer Weight Loss (BWEL) trial, in which women with stage II or III HER2-negative breast cancer achieved an average weight loss of 4.7% of baseline body weight at one year, compared with a 1% weight gain in the education-only control group. The telephone-based intervention, implemented across 637 treatment centers in the U.S. and Canada, coached participants in calorie reduction and increased physical activity. Principal investigator Jennifer A. Ligibel, MD, of Dana-Farber Cancer Institute, remarked that these findings lay the groundwork for future studies assessing whether post-treatment weight loss can reduce cancer recurrence risk and improve long-term survival.

BOSTON - The FDA today granted Breakthrough Therapy Designation to rinatabart sesutecan (Rina-S; GEN1184), an antibody-drug conjugate targeting folate receptor α, for patients with recurrent or progressive endometrial cancer whose disease has advanced after platinum-based chemotherapy and PD-1/PD-L1 therapy. Supported by data from the Phase 1/2 RAINFOL-01 trial, the designation enables expedited development and review of Rina-S. Investigators reported manageable safety profiles, with grade 3-4 cytopenias (including neutropenia in 48.4% of patients) and gastrointestinal events as the most common adverse effects. Genmab’s announcement underscores the urgent need for effective therapies in endometrial cancer and paves the way for larger clinical trials.