FDA grants priority review for Bristol-Myers' Opdivo sBLA

The U.S. Food and Drug Administration (FDA) has granted Bristol-Myers Squibb Co. a priority review for the company’s Opdivo Biologics License Application.
Bristol-Myers wants to approve expanded use of Opdivo to include patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
“We look forward to working with the FDA towards the goal of providing a new treatment option for patients with metastatic colorectal cancer defined by dMMR or MSI-H biomarkers,” Dr. Ian Waxman, development lead for gastrointestinal oncology at Bristol-Myers Squibb, said in a statement.
Waxman noted that these patients likely would not benefit from traditional chemotherapy and therefore need a new solution.
“This milestone illustrates Bristol-Myers Squibb’s continued efforts to evaluate the potential of Immuno-Oncology in a broad range of cancers and represents an important advancement in our approach to translational medicine,” Waxman said.
The company’s submission came after its Phase 2 study that met efficacy endpoints for duration of response, progression-free survival and overall survival.
An FDA decision is expected by Aug. 2.