Yondelis // EEUU /// FDA . """ A Final Approval Decision is Expected From The FDA by Early August """ .

Yondelis Reduce el Riesgo de la Progresíón de la Enfermedad en un 45 % versus el Tratamiento con Dacarbazine en Pacientes con Sarcomas .

Jason M. Broderick @jasoncology /// Published Online: Wednesday, June 3, 2015 .

George D. Demetri, MD

Trabectedin reduced the risk of disease progression by 45% versus dacarbazine in patients with advanced soft tissue sarcoma, according to results from the phase III ET743-SAR-3007 trial presented at the 2015 ASCO Annual Meeting. There was also a slight survival trend with trabectedin, but the results were not significant.

“Trabectedin is confirmed as an important treatment option for relapsed/refractory patients with advanced leiomyosarcoma and liposarcoma,” lead author George D. Demetri, MD, said when presenting the results. “There was a clinically relevant improvement in progression-free survival observed with trabectedin that is superior to the active comparator, dacarbazine,” added Demetri, who is director of the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute.

Based on the data from the trial, the FDA previously granted trabectedin a priority review designation as a treatment for patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have previously received chemotherapy that included an anthracycline.

A Final Approval decision is expected from the FDA by early August.

The open-label, multicenter, phase III SAR-3007 trial compared trabectedin with dacarbazine in 518 patients with liposarcoma and leiomyosarcoma who previously received an anthracycline-containing regimen followed by at least one additional line of chemotherapy. The protocol required patients to have an ECOG performance status of 0 or 1. The study was conducted at 85 sites in four different countries, but Demetri noted that 94% of the patients were enrolled in the United States.

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Yondelis // EEUU /// FDA . Dr. Van Tine on Trabectedin for Leiomyosarcoma and Liposarcoma : Dados los Resultados Positivos Obtenidos en los Ensayos Clínicos Múltiples, Van Tine Espera que la FDA " Apruebe Yondelis " para el Tratamiento de Liposarcomas y Leiomiosarcomas .

Dr. Van Tine on Trabectedin for Leiomyosarcoma and Liposarcoma .

Brian A. Van Tine, MD, PhD
Published Online: Wednesday, June 3, 2015

Brian A. Van Tine, MD, PhD, Assistant Professor Department of Medicine Siteman Cancer Center, Washington University School of Medicine, discusses trabectedin (Yondelis) for the treatment of soft tissue sarcomas.

Trabectedin has been available for over a decade outside of the United States for the treatment of leiomyosarcoma and liposarcoma. It is available at compassionate use centers throughout the United States, but is not currently FDA approved.

It is an exciting drug that has excellent progression-free survival and response rates in leiomyosarcoma and liposarcoma patients, says Van Tine.

Considering its positive results in multiple clinical trials, Van Tine hopes that the FDA will approve the drug for leiomyosarcoma and liposarcoma in the near future.

De los fármacos autorizados en los dos últimos años para consumo humano, el 34 por ciento son nuevas moléculas de productos biotecnológicos .

Los medicamentos biotecnológicos permiten contender con enfermedades complejas y costosas, afirman especialistas.

Debido a su tecnología, estos medicamentos son más eficaces reduciendo días de hospitalización e incrementando calidad de vida de los pacientes .

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