Possible lymphoma link to TNF-blockers sparks agency review
June 6, 2008
The FDA issues Early Communication of immunosuppressants' possible association with lymphoma.
The Food & Drug Administration has asked the manufacturers of tumor necrosis factor (TNF)-blockers-including adalimumab (Humira, Abbott), etanercept (Enbrel, Amgen/Wyeth), infliximab (Remicade, Centocor), and certolizumab pegol (Cimzia, UCB Inc.)-for data on all cases of cancer reported in children and young adults receiving the therapies. According to an Early Communication issued today, the agency said it plans to perform a more thorough review of the data after preliminary findings showed a possible association between the anti-TNF drugs and the development of lymphoma and other cancers in this population of patients. Until the review process is complete, the FDA advises practitioners to weigh the risks and benefits when prescribing the immunosuppressants. Final determinations will be communicated to the public once the review is completed. Amgen and Wyeth Pharmaceuticals issued a statement in response to the agency’s action, pledging support of the ongoing review and a commitment to provide additional information as necessary. TNF-blockers are indicated for treatment of juvenile idiopathic arthritis, Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, and other diseases.