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FDA Approves Trabectedin in Soft Tissue Sarcomas

Jason M. Broderick @jasoncology
Published: Friday, Oct 23, 2015

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has approved trabectedin (Yondelis) for the treatment of patients with unresectable or metastatic soft tissue sarcoma—specfically, liposarcoma and leiomyosarcoma—who have previously received chemotherapy that included an anthracycline.

There were no unexpected toxicities with either of the treatments. All-grade adverse-event (AE) rates were 99.1% and 98.1% in the trabectedin versus dacarbazine arms, respectively, with grade 3/4 AE rates of 76.2% versus 51.6%.

The most commonly reported all-grade AEs with trabectedin versus dacarbazine were nausea (73% vs 49%), fatigue (67% vs 51%), neutropenia (49% vs 29%), increased ALT levels (45% vs 6%), vomiting (44% vs 21%), anemia (39% vs 29%), constipation (36% vs 28%), increased AST levels (35% vs 5%), and diarrhea (34% vs 23%).

Grade 3 AEs with the highest frequency in the trabectedin arm were increased ALT levels (25% vs 1%), neutropenia (21% vs 11%), anemia (14% vs 11%) and increased AST levels (12% vs 0%). Sixteen percent of patients receiving trabectedin had grade 4 neutropenia compared with 10% in the dacarbazine group.

Treatment-related discontinuation rates were 7% and 10% in the dacarbazine and trabectedin arms, respectively. There were treatment-associated deaths within 30 days of the last dose among 3.2% of patients receiving trabectedin compared with none in the dacarbazine arm.

According to a statement from the FDA, trabectedin "carries a warning alerting healthcare providers of the risk of neutropenic sepsis, rhabdomyolysis, hepatotoxicity, extravasation, tissue necrosis, and cardiomyopathy."

Trabectedin was originally derived from a sea squirt, Ecteinascidia turbinate, and is now manufactured synthetically.
 

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