Genmab’s partner Novartis submits sBLA to FDA for ofatumumab to treat relapsed CLL

Ofatumumab is designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.

The sBLA, which was submitted by Novartis under Genmab’s ofatumumab collaboration, is based on interim results from a Phase III trial (Prolong).

The trial evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL.

CLL accounts for about one in four cases of leukemia and most of these patients experience disease progression despite initial response to therapy and may require additional treatment.

Genmab chief executive officer Jan van de Winkel said: "The submission of the application to expand the label to use ofatumumab as a maintenance therapy for patients with relapsed CLL in the US follows closely behind the marketing application for this indication in Europe.

"We are looking forward to the response from both the U.S. and European regulatory authorities, and hope that ofatumumab will soon become available for maintenance therapy of patients with relapsed CLL."

In the US, Arzerra is approved for use in combination with chlorambucil to treat previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.

In the EU, the drug is approved for use in combination with chlorambucil or bendamustine to treat CLL patients who have not received prior therapy and who are not eligible for fludarabine-based therapy.

The company noted that Arzerra is not approved anywhere in the world as maintenance therapy for relapsed CLL.

Image: Peripheral blood smear showing chronic lymphocytic leukemia cells. Photo: courtesy of Mary Ann Thompson.