Novartis has submitted an application to US regulators seeking permission to expand the treatment scope of its Genmab-partnered biologic Arzerra.
If successful, the physicians will be able to prescribe the drug in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukaemia (CLL).
The move follows data from the Phase III COMPLEMENT 2 trial evaluating Arzerra (ofatumumab) in combination with FC versus FC alone in patients with relapsed CLL, which showed that the drug improved median progression free survival (28.9 months versus 18.8 months, respectively).
In the US, Arzerra is already cleared for use in combination with chlorambucil for previously untreated CLL patients for whom fludarabine-based therapy is considered inappropriate, as well as extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
Enbrel for paediatric plaque psoriasis
Meanwhile, Amgen announced that the US Food and Drug Administration is reviewing its supplemental Biologics License Application for the expanded use of Enbrel (etanercept) to treat paediatric patients with chronic severe plaque psoriasis.
"If approved, Enbrel would be the first systemic drug approved in the US to treat chronic severe plaque psoriasis in pediatric patients," said Sean Harper, who heads up Research and Development at Amgen. "We hope to be able to provide paediatric patients with an important new treatment option where there is a clear unmet medical need."
The filing is based on results from a Phase III one-year study and its five-year open-label extension study to evaluate the safety and efficacy of the drug in the target population, and the firm is expecting a decision from the FDA by November 5.