Velcade® receives FDA approval for subcutaneous administration

The way Velcade is given is set to change with the announcement that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous administration of Velcade for the treatment of myeloma.

At present, Velcade is given by intravenous injections. Although very effective in treating myeloma, intravenous Velcade has two major drawbacks with patients needing to go to hospital to receive it and the occurrence of peripheral neuropathy, a common and debilitating side-effect.

The results of an international Phase III study published last summer led to the submission of a supplementary New Drug Application by its manufacturer Millennium and its parent company Takeda Pharmaceuticals Company Ltd.

The study found that subcutaneous (beneath the skin) injection of Velcade was equally effective as conventional intravenous (into the vein) injection in treating relapsing myeloma patients. However, subcutaneous Velcade significantly reduced the incidence and severity of peripheral neuropathy as well as other side-effects such as gastro-intestinal disturbances.

The approval of subcutaneous Velcade by the FDA is expected to be followed soon by approval from their European counterparts, the European licensing agency, the European Medicines Agency (EMA).

Eric Low, Chief Executive, Myeloma UK said, “We welcome the FDA’s decision to approve the administration of Velcade via subcutaneous injection. We look forward to a decision by the EMA and we will do all we can to ensure that subcutaneous Velcade is made available in the UK as soon as possible.”

To find out more about subcutaneous Velcade, speak to your doctor or contact the Myeloma Infoline on 0800 980 3332.