Novartis and Genmab are seeking approval from the US Food and Drug Administration (FDA) for their ofatumumab (Arzerra) as maintenance therapy for patients with relapsed chronic lymphocytic leukaemia (CLL).
Ofatumumab is a human monoclonal antibody, which is developed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.
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Under Genmab’s ofatumumab collaboration, Novartis has submitted a supplemental biologics licence application (sBLA) to the FDA for the uses of ofatumumab as maintenance therapy of patients with CLL.
The sBLA was submitted based on interim results from a Phase III study, Prolong (OMB112517), which assessed ofatumumab maintenance therapy against no further treatment in patients with a complete or partial response after second or third line treatment for CLL.
Genmab CEO Dr 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 US and European regulatory authorities, and hope that ofatumumab will soon become available for maintenance therapy of patients with relapsed CLL."
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By GlobalDataIn the US, Arzerra received approval for use in combination with chlorambucil to treat previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
In the EU, Arzerra obtained approval for use in combination with chlorambucil or bendamustine to treat patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Arzerra is also indicated as monotherapy to treat patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab, in around 50 countries worldwide.
Under the co-development and collaboration agreement, Genmab and Novartis, as successor in interest to GSK, markets Arzerra in different countries.
Image: Peripheral blood with chronic lymphocytic leukaemia. Photo: courtesy of Gabriel Caponetti.
