FDA approves VELCADE plus DOXIL combination for multiple myeloma

May 23 2007

Ortho Biotech Products has announced the U.S. Food and Drug Administration (FDA) has approved the use of DOXIL (doxorubicin HCl liposome injection) in combination with VELCADE (bortezomib) for Injection 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 the results of an international Phase III trial comparing the VELCADE + DOXIL combination to VELCADE alone. The research showed that when used together to treat patients with relapsed/refractory multiple myeloma, the two medications significantly extended the median time to disease progression (TTP) from 6.5 months to 9.3 months (p<0.0001; HR 0.55; 95% CI (0.43, 0.71)) over VELCADE alone.

"This approval means that the VELCADE + DOXIL combination offers an important new option for treating relapsed or refractory multiple myeloma," says Robert Orlowski. M.D., Ph.D., from the University of North Carolina, Lineberger Comprehensive Cancer Center in Chapel Hill, and principal investigator of the trial. "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."

Multiple myeloma is a cancer of the plasma cell, an important component of the immune system. It is the second most prevalent hematologic (blood-related) cancer, after non-Hodgkin's lymphoma.(1) The American Cancer Society estimates that close to 20,000 new cases of multiple myeloma will be diagnosed in the United States this year.(2)

"The VELCADE + DOXIL combination represents an important new therapeutic option for multiple myeloma, a disease that is incurable and has limited treatments available," adds Kathy Giusti, Chief Executive Officer and Founder of the Multiple Myeloma Research Foundation, and a myeloma patient. "The FDA approval of this promising combination signifies a critical milestone in the quest to treat patients with multiple myeloma."

The FDA approved Ortho Biotech's Supplemental New Drug Application (sNDA) for the VELCADE + DOXIL combination under the agency's Priority Review program. The approval was based on a pre-planned, interim analysis from the DOXIL-MMY-3001 study, an international, multi-center, phase III, randomized, open-label study of 646 patients with relapsed or refractory multiple myeloma who had not previously received VELCADE. For more information about the DOXIL-MMY-3001 study results, go to: http://www.orthobiotech.com/releaseDetail.jsp?releaseID=300001

In addition to this new approval, DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. The FDA also has granted accelerated approval for DOXIL for the treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination chemotherapy, or in patients who are intolerant to such therapy.

"As a company, we are dedicated to the development of treatments for cancer that will make a significant difference in patients' lives," says Craig Tendler, M.D., Vice President, Oncology Clinical Affairs, Ortho Biotech. "This approval is another positive development in our partnership with Millennium, and we are pleased the FDA expedited the process of making the VELCADE + DOXIL combination available to patients with previously treated multiple myeloma."