Johnson & Johnson’s Janssen Pharmaceutical is seeking extension of approval in the European Union for Darzalex (daratumumab) in a subcutaneous formulation for the treatment of multiple myeloma.
In this regard, the company has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous use of daratumumab, co-formulated with recombinant human hyaluronidase PH20 (rHuPH20).
The submission of the extension application is backed by the data from the phase 2 PLEIADES (MMY2040) trial and the phase 3 COLUMBA (MMY3012) trial.
Janssen-Cilag Europe, Middle East and Africa (EMEA) haematology therapy area lead Patrick Laroche said: “This new formulation is an example of our unwavering commitment to pursue innovative treatment options to support people living with multiple myeloma.
“Importantly, subcutaneous daratumumab demonstrated comparable efficacy with the existing IV formulation, reduced the rate of infusion-related reactions and significantly shortened the time it takes for patients to receive treatment, from several hours to approximately five minutes.”
Currently, the drug is only approved for intravenous (IV) use. In Europe, the drug in combination with bortezomib, melphalan and prednisone, is indicated for newly diagnosed multiple myeloma.
It is also approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of multiple myeloma and as a monotherapy for relapsed and refractory multiple myeloma.
Janssen Research & Development oncology clinical development and global medical affairs vice president Craig Tendler said: “Janssen has an extensive heritage in multiple myeloma and we are committed to developing innovative approaches to minimise the treatment burden for patients with multiple myeloma.
“We look forward to working with the EMA in its review of the data supporting this application.”
The company is also seeking approval of the new daratumumab subcutaneous formulation having filed a biologics license application (BLA) with the US Food and Drug Administration (FDA).
The drug has been designed to target CD38, which is a highly expressed a surface protein found across multiple myeloma cells, irrespective of disease stage.
According to Janssen, daratumumab is thought to induce tumour cell death by various immune-mediated mechanisms of action such as complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cell-mediated cytotoxicity (ADCC) among others.