Harpreet Singh

Opinion Author

Harpreet Singh is the chief medical officer of Precision for Medicine, a global leader in biomarker-driven clinical research and development. Previously, Dr. Singh was director of the FDA’s Division of Oncology 2, Office of Oncologic Diseases, a division that regulated drugs and biologics for the treatment of thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors. In addition, Dr. Singh applied her large body of work in geriatrics as associate director for cancer in older adults and special populations at the FDA Oncology Center of Excellence (OCE). She was previously a Fellow at the National Cancer Institute.

Close-Up Of Medicine Bottles Against Green Background

Opinion

FDA Faces Challenging Decision on Biomarker-Based Label Restrictions

The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo in stomach and esophageal cancers based on PD-L1 expression levels—but the high unmet need in these patient populations should also be considered.

March 10, 2025

5 min read

Harpreet Singh