GlaxoSmithKline and Genmab are celebrating the news that regulators in the USA have granted a priority review to the firm’s fully human monoclonal antibody Arzerra.
Specifically, the US Food and Drug Administration has accepted the Biologics License Application for Arzerra (ofatumumab) to treat patients whose chronic lymphocytic leukaemia is resistant to previous therapies and granted the drug priority review status. This means that the FDA sets the target date for a decision on Arzerra at six months, rather than the standard 10-month review.
If approved, Genmab noted that ofatumumab would be the first monoclonal antibody targeted to CD20 available for this patient population. The Denmark-headquartered company also noted that the FDA has granted ofatumumab orphan designation for CLL; it is also being developed in late-stage trials as a treatment for rheumatoid arthritis and non-Hodgkin’s lymphoma.
The acceptance of the BLA will trigger a milestone payment from GSK to Genmab of 87 million Danish kroner ($15 million). The Copenhagen-based group will also receive a one-time payment of $4.5 million from GSK in exchange for terminating its option to co-promote Arzerra.
The companies also noted that to expand the use of ofatumumab in earlier stages, enrollment will begin shortly for an additional Phase III study of the drug in combination with fludarabine and cyclophosphamide as a second-line treatment for patients with refractory CLL.
