Millennium: The Takeda Oncology Company announced today that the U.S Food and Drug Administration has approved subcutaneous administration of Velcade for the treatment of multiple myeloma and relapsed mantle cell lymphoma.

Velcade ^[1] (bortezomib), which is marketed by Millennium and its parent company Takeda Pharmaceutical Company Limited (TSE:4502), is currently approved to be administered intravenously (infused into a vein).

The FDA decision to approve the subcutaneous administration of Velcade (injection into fat just below the skin, often abbreviated as subcu or subQ) was based on results of a Phase 3 study comparing subcutaneous and intravenous administration of Velcade for myeloma patients.

The results showed that subcutaneous Velcade is as effective as intravenous Velcade, but subcutaneous administration reduces the frequency and seriousness of side effects.  In particular, subcutaneous Velcade causes less peripheral neuropathy, pain and tingling in the extremities and a common side effect of Velcade (see related Beacon ^[2] news).

In addition to being safer, subcutaneous Velcade may be more convenient for many patients.  Subcutaneous administration is faster and does not require an accessible vein.  Currently, subcutaneous Velcade is being administered in hospitals or clinics by health care professionals, but eventually patients may be able to administer it at home.

Although subcutaneous administration of Velcade was not officially approved by any regulatory agencies until today, some physicians in the United States and several other countries have been administering Velcade subcutaneously since the release of the clinical trial results showing better tolerability (see related Beacon ^[3] news).

The prescribing information for Velcade will be updated to say that Velcade can be used via intravenous or subcutaneous administration, but not intrathecal administration (injection into the spinal canal).  Inadvertent injection into the spinal canal has resulted in death.

For more information about the FDA approval, see the Millennium ^[4] press release.