FDA D.I.S.C.O. Burst Edition: FDA approves updated drug labeling including new indications and dosing regimens for Xeloda (capecitabine) tablets under Project Renewal
Regulatory approval: On Dec 14, 2022, the FDA approved updated labeling for capecitabine tablets (Xeloda) under the Oncology Center of Excellence’s Project Renewal pilot program. The revised label includes new and updated indications across colorectal, rectal, breast, gastric/GEJ/esophageal, and pancreatic cancers, along with updated dosing and safety information. The update also revises sections on renal impairment, exposure risks from crushed tablets, dihydropyrimidine dehydrogenase deficiency, clinical pharmacology, and patient counseling materials.
FDA labeling update (Project Renewal): capecitabine (Xeloda)
Type: Regulatory approval (labeling update)
On Dec 14, 2022, the FDA approved updated labeling for capecitabine tablets (Xeloda) under Project Renewal, an FDA Oncology Center of Excellence initiative to update labeling for older oncology drugs based on published literature and post-marketing experience. FDA stated this is the first drug to receive a labeling update under the pilot program.
New and revised indications now included
Xeloda is now approved for:
- Stage III colon cancer (adjuvant): single agent or in combination chemotherapy.
- Locally advanced rectal cancer (perioperative): as part of chemoradiotherapy.
- Unresectable/metastatic colorectal cancer: single agent or in combination chemotherapy.
- Advanced/metastatic breast cancer: single agent when anthracycline- or taxane-containing chemotherapy is not indicated.
- Advanced/metastatic breast cancer: with docetaxel after progression on prior anthracycline-containing chemotherapy.
- Unresectable/metastatic gastric, esophageal, or GEJ cancer: as part of combination chemotherapy.
- HER2-overexpressing metastatic gastric/GEJ adenocarcinoma (previously untreated metastatic): as part of a combination regimen.
- Pancreatic adenocarcinoma (adjuvant): as part of combination chemotherapy.
Additional labeling revisions
FDA noted revised dosing for several indications (including an option for a lower starting dose in metastatic breast cancer), removal of severe renal impairment as a contraindication, added warnings on crushed-tablet exposure, expanded information on DPD deficiency, and updates to clinical pharmacology and patient counseling materials.