Johnson & Johnson unit Janssen-Cilag International has withdrawn its application to extend the therapeutic indication for its cancer drug Velcade (bortezomib) in the European Union.
The drugmaker was seeking approval for the use of Velcade in combination with rituximab as a treatment for patients with relapsed follicular non-Hodgkin lymphoma.
However, in a statement released by the European Medicines Agency, the regulator said it had been formally notified by the company that it was pulling the file because the Committee for Medicinal Products for Human Use indicated that the data underpinning its application do not support a positive benefit-risk balance.
Velcade continues to be authorised in its currently approved indications: in combination with melphalan and prednisone to treat patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with a bone marrow transplant; and to treat progressive multiple myeloma in patients who have received at least one prior therapy and have already had or are unsuitable for a bone marrow transplant.
Just last month, the CHMP issued a positive opinion on the subcutaneous administration of the drug, after a Phase III study showed it to be just as effective as the traditional intravenous route.
"If approved, subcutaneous administration will be the administration of choice versus intravenous, combining better tolerability with maintained high efficacy," noted Jane Griffiths, Company Group Chairman of Janssen Europe, Middle-East and Africa.