Response letter received regarding new drug application for kidney cancer agent

"While the addition of an ICI to low dose FOTIVDA did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations," says Michael P. Bailey.

“When you compound the patient delay and…the physician delay, then you really get a delay in diagnosis,” says Curtis A. Pettaway, MD.

“These findings provide a plausible mechanism for the enhanced clinical outcome with CBM588 now seen across 2 small, randomized trials,” write the authors.

“Because so many disease processes that we deal with are related to tobacco use and smoking specifically… I think this is absolutely our domain,” says Richard S. Matulewicz, MD, of tobacco cessation counseling and treatment.

This announcement comes on the heels of an FDA acceptance of an investigational new drug application for ADI-270 in June.

CBM588 could be exciting in cancer treatment because of its potential to enhance the efficacy of immune checkpoint inhibitor-based treatment, improve patient outcomes, and modulate the gut microbiota in beneficial ways,” says Sumanta Pal, MD.