Table 7

Malignancies reported for the overall safety population

IndicationAge/ sexVedolizumab doses*Malignancy (PT)Prior therapy
Placebo-controlled studies
 UC70.7/F0Basal cell carcinoma
Squamous cell carcinoma
 UC40.5/M2Transitional cell carcinomaAZA, 6MP, CS†
 UC73.7/M2Colon cancerAZA, 6MP, CS
 UC32.7/M7Colon cancerAZA†, 6MP, IFX, CS†
 CD45.2/F2Breast cancerAZA, 6MP, CS†
 CD52.1/F10Squamous cell carcinomaADA, IFX, AZA, 6MP, MTX, CS
 CD20.7/F13Carcinoid tumour of the appendixADA, IFX, AZA, 6MP, CS
Open-label studies
 UC47.4/M2Malignant melanomaIFX, AZA†, 6MP, MTX, CS
 UC75.3/F3Lung neoplasm malignantAZA, 6MP, IFX, CS
 UC63.5/M6Breast cancer in situMTX, IFX, AZA, CS
 UC44.1/M8Metastases to peritoneumIFX, CS, AZA
 UC70.2/M9Malignant melanomaIFX, AZA, 6MP, CS
 UC50.4/M29Renal cancerCS
 CD69/F3Lung neoplasm malignant (hepatic neoplasm malignant)MTX, ADA, IFX, AZA, 6MP, CS†
 CD45.5/F8Colon cancerIFX, AZA, 6MP, CS†
 CD46.8/M12Basal cell carcinomaIFX, ADA, AZA, 6MP, MTX, CS
 CD42.9/M21B cell lymphomaAZA†, 6MP, IFX, CS†, rituximab†
 CD49.7/M37Squamous cell carcinomaAZA†, 6MP, CS
 CD51.1/F41Hepatic neoplasm malignantADA, AZA, 6MP, CS
  • *Infusions before or on the first occurrence of selected adverse events. For patients who participated in multiple clinical studies, all doses of vedolizumab were counted.

  • †Continued use on study.

  • 6MP, mercaptopurine; ADA, adalimumab; AZA, azathioprine; CD, Crohn's disease; CS, corticosteroids; GLM, golimumab; IFX, infliximab; MTX, methotrexate; PT, preferred term; UC, ulcerative colitis.