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.

“This is an important endpoint for these patients, in whom rapid worsening of the disease can lead to worse symptoms and life-threatening situations.

“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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.