Velcade/Doxil Approved for Relapsed or Refractory Multiple Myeloma Pts

ROCKVILLE, Maryland—The US Food and Drug Administration (FDA) has approved the use of Doxil (doxorubicin liposome injection, Ortho Biotech) in combination with Velcade for Injection (bortezomib, Millennium) to treat patients with multiple myeloma who have not previously received Velcade and have received at least one prior therapy.

The approval is based on a preplanned interim analysis from the international phase III randomized, open-label DOXIL-MMY-3001 trial, which compared Doxil/Velcade to Velcade alone in 646 patients with relapsed/refractory multiple myeloma who had not previously received Velcade. The combination significantly improved median time to progression from 6.5 months to 9.3 months (HR 0.55, P < .0001) (see February ONI, page 3).

"This approval means that the Velcade plus Doxil combination offers an important new option for treating relapsed or refractory multiple myeloma," said principal investigator Robert Orlowski, MD, PhD, of the University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill. "This is particularly significant because we need treatment options that improve the prognosis for patients whose disease has not responded to their first round of therapy."