US FDA Approves Priority Review of Opdivo
On January 22nd, 2021, the United States Food and Drug Administration (FDA) approved a priority review of Opdivo (nivolumab), a PD-1 inhibitor manufactured by Bristol Meyer Squibb, for the treatment of unresectable advanced or metastatic gastric cancer, esophageal adenocarcinoma, or gastrointestinal junction cancer.
Before approved for use, each drug marketed in the United States must go through a detailed FDA review process. Under the Prescription Drug User Act (PDUFA), the FDA created two classes of review times – Standard Review and Priority Review.
A Priority Review designation allows the FDA to take action on an application within 6 months. This will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
For comparison, a Standard Review takes up to 10 months for the FDA to take action.
- Dobkowski, Darlene. “FDA Grants Priority Review For Opdivo For Several Gastrointestinal Cancers”. Cure Today, 2021, https://www.curetoday.com/view/fda-grants-priority-review-for-opdivo-for-several-gastrointestinal-cancers.
- “Priority Review”. U.S. Food And Drug Administration, 2021, https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.