FDA green light also marks conversion from accelerated to regular approval.
Genzyme’s and Bayer HealthCare Pharmaceuticals’ leukemia drug, which was launched in 2001 under accelerated approval, has won full approval as well as a label-expansion.
The FDA’s Division of Biologic Oncology Products sanctioned the firms’s BLA for Campath, triggering the conversion and allowing the therapy as a first-line treatment for B-cell chronic lymphocytic leukemia (B-CLL).
Campath, reportedly the first and only mAb against B-CLL, thus far has been marketed for patients who have failed two types of treatment. The companies report that a label expansion into initial use is being considered in Europe.