Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of subcutaneous (under the skin) administration of VELCADE(R) (bortezomib). VELCADE(R) is indicated for the treatment of multiple myeloma, a type of blood cancer. Subcutaneous bortezomib has fewer side effects and offers greater convenience for patients, with similar efficacy compared to intravenous bortezomib. VELCADE(R) plays a central role in effectively managing multiple myeloma across different patient types and lines of therapy.[1,2]
The CHMP positive opinion is based on a Phase 3 study comparing subcutaneous and intravenous administration of bortezomib for relapsed myeloma patients. The results showed that subcutaneous bortezomib is as effective as intravenous (directly into a vein) bortezomib, but subcutaneous administration reduces the frequency and seriousness of side effects. In particular, subcutaneous bortezomib causes significantly less peripheral neuropathy, pain and tingling in the extremities, a common side effect of bortezomib.
The CHMP is the committee responsible for the scientific assessment of products seeking centralised marketing authorisation throughout the European Union. The CHMP's positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission in mid-2012.
Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa, commented: "This positive opinion is a decisive step in making subcutaneous bortezomib available to all patients who suffer from multiple myeloma. If approved, subcutaneous administration will be the administration of choice versus intravenous, combining better tolerability with maintained high efficacy."
Subcutaneous bortezomib also offers an alternative choice for patients with poor venous accessibility or those at risk of, or with pre-existing, peripheral neuropathy, for whom bortezomib IV may previously not have been an option.
Subcutaneous bortezomib was approved in the USA by the Food and Drug Administration (FDA) for the treatment of multiple myeloma and relapsed mantle cell lymphoma in January 2012, and by Health Canada for the treatment of multiple myeloma in March 2012.