Oncology

The FDA approved Celcuity's gedatolisib for PIK3CA wild-type HR+/HER2- advanced breast cancer after it more than tripled progression-free survival over fulvestrant alone in the Phase 3 VIKTORIA-1 trial.

A single intravenous dose of the frog-gut bacterium Ewingella americana produced complete tumor regression in every treated mouse in a colorectal cancer model, outperforming anti-PD-L1 immunotherapy and chemotherapy, JAIST researchers report in Gut Microbes.

Five-year overall survival was non-inferior when surgeons omitted completion axillary dissection, while severe arm problems fell from 12.6% to 3.6%.

The 4,429-patient Phase III OPTIMA trial found that a Prosigna ROR-guided strategy was non-inferior to standard chemotherapy in ER-positive, HER2-negative early breast cancer, letting 68% of clinically high-risk patients skip chemo.

Scientists have developed Glycan Atlasing, a super-resolution technique that reads shifting sugar patterns on cell surfaces to distinguish cancer stages from healthy tissue and activated from resting immune cells.

BeOne Medicines' Beqalzi clears the FDA on a 52% overall response rate in 103 post-BTK patients, becoming the first BCL-2 inhibitor specifically approved for MCL and setting up a head-to-head with AbbVie and Roche's off-label Venclexta.

Phase 3 RASolute 302 data show the oral RAS inhibitor extending median overall survival to 13.2 months versus 6.7 months on chemotherapy, sending Revolution Medicines shares up nearly 40 percent.