The dawn of the cancer immunotherapy era has brought with it renewed hope in the treatment of patients with advanced tumors. While the immune checkpoint inhibitors have offered strong and durable cancer control to some patients, the reality is that not all patients benefit from these treatments. Many studies have included assessment of potential biomarkers […]

Promoting the use of patient-focused outcome measurement in drug development has been a major focus of the United States Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). To continue fostering this goal, the CDER recently published an update of their Clinical Outcome Assessment (COA) Compendium. This compilation was designed to act […]

In breast, ovarian, and pancreatic cancer, deficiencies in genes related to homologous recombination repair (HRR), including BRCA1/2 and ATM, are known to be associated with increased sensitivity to poly(ADP-ribose) polymerase (PARP) inhibitors. According to preliminary results from the ongoing phase III PROfound trial, prostate cancer can now be added to this list. In a recent […]