Health Canada Approves Trabectedin for Relapsed Ovarian Cancer

Yael Waknine

May 26, 2010

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 1 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/m2) plus doxorubicin (30 mg/m2) in 3-week cycles significantly increased progression-free survival by 21% compared with PLD alone (50 mg/m2) 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. Clinical trials are currently evaluating its use with other soft tissue sarcomas (eg, translocation-associated tumors, Ewing's sarcoma, and rhabdomyosarcoma), as well as prostate, breast, and lung cancer.

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