New Arthritis Drug Causing Lymphoma Concerns at FDA

Pfizer's newest experimental drug for the treatment of rheumatoid arthritis, tofacitinib, has caused major concerns in clinical trials, according to regulators evaluating the data, including the possibility of causing lymphomas.

In a report written ahead of a May 9 meeting to discuss the benefits and risks of
tofacitinib, FDA personnel are saying that the oral medication demonstrates high risk of infection and malignancies, specifically noting lymphoma.

Another problem with the data is that it doesn't suggest that tofacitinib has any progression-free benefits to patients either.

The auto-immune disease rheumatoid arthritis, in which the body's immune system attacks joints in the body, affects as many as 1.3 million Americans annually. Tofacitinib is a major oncology product in Pfizer's drug portfolio.

If given approval, tofacitinib would be, according to Pfizer, the first new pill for rheumatoid arthritis in at least a decade. Its approval would likely be limited to patients who have failed methothrexate treatment or Humira injection.

Source: Bloomberg