FDA approves Janssen’s Yondelis

HORSHAM, Pa. — The Food and Drug Administration on Monday approved Janssen Biotech’s Yondelis (trabectedin), a treatment for patients with two subtypes of soft tissue sarcoma, leiomyosarcoma and either metastatic or unresectable liposarcoma (LPS). According to the company, it’s the first drug approved specifically for LPS.

“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,” said Dr. George Demetri, principal investigator of the Phase 3 registration trial. “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.”

Janssen will use its CarePath Savings Program to assist eligible patients with out-of-pocket costs, the company said.