FDA Revises Golimumab Label to Reflect Lymphoma and Leukemia Risk

The U.S. FDA revised the labeling of warnings and precautions for golimumab to reflect safety information regarding the incidence of lymphoma and leukemia among patients receiving the drug. This warning is similar to that of other tumor necrosis factor (TNF)-alpha inhibitors.

Golimumab is approved for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, and ulcerative colitis.

The revised warning includes the following updates:

  • Patients with RA and other inflammatory disease may have a higher risk for lymphoma and leukemia in the absence of TNF inhibitors; most patients who developed lymphoma received azathioprine or 9-mercaptopurine.
  • The formation of anti-nuclear antibodies related to lupus-like syndrome in patients who received TNF inhibitors was also reported in this labeling revision.
  • An increased risk for worsening or new-onset congestive heart failure (CHF) and a recommendation that patients with CHF be monitored as a precaution when taking TNF inhibitors.

The incidence of lymphoma and leukemia was detected in controlled portions of clinical trials of golimumab, and these updates are not the result of new safety data, according to the drug’s manufacturer.

Source: Janssen Biotech press release, January 13, 2016.