Genmab has won a $23 million milestone payment from GlaxoSmithKline on the FDA's approval of Arzerra (ofatumumab) for chronic lymphocytic leukemia. The FDA provided an accelerated approval of the antibody therapy--which Glaxo licensed three years ago in a $2.1 billion deal--for leukemia patients who have not responded to other therapies.
The regulatory OK is a big win for Genmab. This is its first approval for one of its antibody programs. Arzerra is designed to attach to the CD20 molecule found on B cells, which are vulnerable to leukemia. It flags the cells for destruction, much like Rituxan does, though it uses a different mechanism. The approval is based on data from a pivotal study in which 42 percent of patients with CLL who were refractory to both fludarabine and alemtuzumab (two therapies used in treating CLL) responded to treatment with Arzerra.
It hasn't all been clear sailing for the Danish biotech, though. A late-stage trial of Arzerra for non-Hodgkin's lymphoma produced disappointing results last summer, forcing the developer to trim its revenue forecast by $142 million as it subtracted an expected milestone from Glaxo. The therapy is also being tested as a treatment for rheumatoid arthritis.
"The approval of Arzerra illustrates FDA's commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options," said Richard Pazdur, director of the Office of Oncology Drug Products.
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