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ODAC voted against two drug therapies for ovarian and breast cancer
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The FDA Oncologic Drugs Advisory Committee yesterday voted 14-1 against recommending the use of trabectedin plus doxorubicin HCl liposome injection for the treatment of relapsed ovarian cancer. The panel also voted 13-0 against the use of doxorubicin HCl liposome injection plus docetaxel for the treatment of locally advanced or metastatic breast cancer.
Based on findings presented from a phase-3 trial, the expert panel decided that a six-week increase (HR=0.79) in PFS was not sufficient to approve therapy with trabectedin, proposed trade name Yondelis (Centocor Ortho Biotech), plus doxorubicin HCl liposome injection (Doxil, Centocor Ortho Biotech) for treatment of patients with ovarian cancer.
Specifically, the ODAC noted a significant increase in severe and life-threatening adverse events in the treatment group.
William Kelly, DO, associate professor of Medicine and Medical Oncology at the Yale Cancer Center, in New Haven, Conn., voted against the therapy.
“The combination appears to have modest clinical activity; however, the small increase in PFS without an improvement in quality of life or overall survival lead me to suspect this may not be beneficial in this population of patients,” he said during the meeting.
Additionally, based on findings from a randomized trial, the ODAC decided that treatment with doxorubicin HCl liposome injection plus docetaxel for locally advanced or metastatic breast cancer did not demonstrate a sufficient benefit-risk profile.
Therapy treatment demonstrated a 2.6-month improvement in time to tumor progression (HR=0.65; 95% CI, 0.55-0.77), yet was associated with a marked increase in adverse events, including cycle delays, dose reductions and permanent drug discontinuation.
“The drug showed marginal benefit; survival trumps everything, and this therapy has failed to show utility in that regard,” said panel member Ronald Richardson, MD, of the division of medical oncology at the Mayo Clinic in Rochester, Minn.
Another panel member, S. Gail Eckhardt, MD, professor of medicine at the University of Colorado, said: “I had concerns about the applicability and integration of this treatment in the population.”
The drug company released a statement indicating it will continue to work with the FDA to address the ODAC’s concerns regarding the two drug therapies.