Clinical Factors Impacting Risk Assessment, Prognosis, and Progression

The FDA converted the accelerated approval of pembrolizumab in TMB-high solid tumors to traditional approval, redefining TMB-high as at least 13 mut/Mb.

Following an end-of-phase 2 meeting with the FDA, Rgenta plans to start a phase 3 trial of oral RGT-61159 in adenoid cystic carcinoma in the first quarter of 2027.

The FDA granted fast track designation to SBE303, Samsung Bioepis’ investigational Nectin-4–targeting ADC, for advanced urothelial cancer following enfortumab vedotin.

The antibody-drug conjugate sofetabart mipitecan showed efficacy and safety, leading to selection of a phase 3 dose for the FRAmework-01 trial.

FDA grants orphan drug designation to onvansertib for relapsed or refractory CMML, boosting development of the PLK1 inhibitor after early signals of activity.

Findings highlight the need for individualized monitoring after discharge, despite low rates of severe toxicities.

During a live event, Robert Orlowski, MD, PhD, and participants discussed how access barriers, disease tempo, and bridging choices shape CAR T referral for a patient with early relapsed multiple myeloma.

The guidelines incorporate cosibelimab for locally advanced cutaneous squamous cell carcinoma after favorable results in the CK-301-101 trial.