Janssen Biotech announced that the U.S. Food and Drug Administration (FDA) approved Yondelis (trabectedin) for the treatment of patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) who received a prior anthracycline-containing regimen. It is worth pointing out that Janssen is a subsidiary of Johnson & Johnson (NYSE: JNJ).

This approval was based on recently published clinical efficacy and safety data from the phase 3, randomized, open-label, controlled study (ET743-SAR-3007), which evaluated Yondelis versus the chemotherapy agent dacarbazine, in these patients.

While it is approved for both LPS and LMS, Yondelis is the first treatment to be specifically approved for LPS in the U.S. Since the drug was first approved in Europe in 2007, roughly 50,000 patients in close to 80 countries have benefited from this therapy across all indications.

George D. Demetri, M.D., Director of the Ludwig Center at Harvard and Director of the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute, and principal investigator of the phase 3 registration trial, 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.

Shares of J&J were up 0.7% at $100.20 late on Friday, with a consensus analyst price target of $107.58 and a 52-week trading range of $81.79 to $109.49.

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