Bristol-Myers Squibb Company said the ongoing phase III CheckMate-227 study met its co-primary endpoint of progression-free survival with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer patients whose tumors have high (≥10 mutations/megabase, mut/mb) tumor mutation burden, regardless of PD-L1 expression.
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
