Janssen Biotech has received approval from the US Food and Drug Administration (FDA) for Yondelis (trabectedin) to treat patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) who received a prior anthracycline-containing regimen.
The approval was based on data from a randomised, open-label, controlled Phase III trial (ET743-SAR-3007), which evaluated the efficacy and safety of Yondelis versus the chemotherapy agent dacarbazine, in patients with unresectable or metastatic LPS or LMS previously treated with an anthracycline and at least one additional chemotherapy regimen.
Yondelis has been approved for both LPS and LMS, and is the first treatment to be specifically approved for LPS in the US.
Dana-Farber Cancer Institute Center for Sarcoma and Bone Oncology director and principal investigator of the Phase III registration trial George Demetri said: “Our academic teams are dedicated to finding new treatments with scientific merit and the promise to improve outcomes for patients with sarcomas.
“Today’s announcement marks a meaningful event built upon years of research, offering new hope for people living with two of the most prevalent subtypes of this serious disease, liposarcoma and leiomyosarcoma, where there are limited available alternatives.
“In the clinical trial, Yondelis significantly increased progression free survival compared to dacarbazine; this is an important endpoint for these patients, in whom rapid worsening of the disease can lead to worse symptoms and life-threatening situations.”
More than 500 patients were included in the trial, which showed an improvement in progression-free survival (PFS) for patients treated with Yondelis.
The company noted that the median PFS among the Yondelis treatment group was 4.2 months, while the median PFS in the dacarbazine treatment group was 1.5 months, representing a 45% reduction in the risk of disease progression or death with Yondelis.
The final analysis of overall survival (OS) showed a median OS of 13.7 months for the Yondelis arm and 13.1 months in dacarbazine arm, which was not significant.
The company said that the recommended dose of Yondelis is 1.5mg/m2 administered as an intravenous infusion over 24 hours through a central venous line every 21 days until disease progression or unacceptable toxicity in patients with normal bilirubin and AST or ALT, less than or equal to 2.5 times the upper limit of normal.