Janssen’s Velcade receives expanded EU approval

Janssen has announced that the European Commission has approved its multiple myeloma drug Velcade in an expanded indication.

It has been ratified as an induction therapy in combination with dexamethasone or thalidomide and dexamethasone among adult patients with previously-untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation.

Data from two phase III trials showed that the drug can deliver improvements in post-induction and post-transplant response rates and in progression-free survival for this patient group.

Previously, Velcade was limited to use in combination with melphalan and prednisone among multiple myeloma patients who were previously untreated and ineligible for stem cell transplant, or as a single agent in advanced multiple myeloma.

Janssen said: "Multiple myeloma, a type of blood cancer, currently affects around 60,000 people in Europe. This decision could mean significantly improved outcomes for many patients with this disease."

This comes after the manufacturer received recommendations from Europe's Committee for Medicinal Products for Human Use for approval of new indications for its drugs Simponi and Stelara last month.