May 26, 2010 — Health Canada has approved trabectedin (
Yondelis;
PharmaMar SA [Zeltia SA], marketed by Centocor Ortho Biotech Products,
LP) in combination with pegylated liposomal doxorubicin (PLD) for the
treatment of relapsed platinum-sensitive ovarian cancer.
The treatment is indicated for
patients who have failed (blogger comment - ho hum!) first-line
platinum-based chemotherapy regimen, including adjuvant therapy, and who
are not expected to benefit from, are ineligible for, or are unwilling
to undergo additional platinum-based chemotherapy.
Approval was based on radiologic data from a multinational phase 3
clinical study (n = 672) showing that administration of trabectedin (1.1
mg/m
2) plus doxorubicin (30 mg/m
2) in 3-week
cycles significantly increased progression-free survival by 21% compared
with PLD alone (50 mg/m
2) given every 4 weeks (7.3 months vs
5.8 months; hazard ratio [HR], 0.79;
P = .019).
These findings were confirmed by an independent radiologic assessment
that considered clinical as well as radiologic imaging data in
assessing tumor progression (HR, 0.72;
P = .0008). These study
results were presented at the 2008 European Society for Medical Oncology
Congress, and
reported by
Medscape Oncology during the
conference.
In July 2009, the FDA declined approval of trabectedin for ovarian
cancer, citing the potential for variations in radiologic data
assessment and questioning whether the 6-week increase in
progression-free survival offset an increased risk for toxicity, as
previously
reported by
Medscape Oncology.
Trabectedin previously was approved in the European Union for the
treatment of platinum-sensitive ovarian cancer and soft tissue sarcoma.
