On Dec. 24, 2022, the U.S. Food and Drug Administration (FDA) approved updated labeling for Genentech’s capecitabine tablets (brand name Xeloda) under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.

This was the first drug to receive a labeling update under this pilot program. Project Renewal is limited to updating labeling of older oncology drugs with decades of use, multiple supportive clinical studies, and substantial post-marketing experience.

Xeloda (capecitabine) was previously approved in 1998 for the treatment of adjuvant colon cancer, metastatic colorectal cancer and metastatic breast cancer.