Five years after the FDA formally rejected J&J's ($JNJ) Yondelis (trabectedin) for ovarian cancer, and three years after an aborted effort to get it back on track, the pharma giant has finally made its way back to the agency for another try at an approval--this time as a treatment for soft tissue sarcoma.
The FDA barred the door to an approval after outside experts balanced the signs of increased adverse events against a 6-week improvement in progression-free survival. Regulators ultimately decided they wanted more late-stage data to back the app.
J&J is making its comeback effort with a Phase III study involving more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. Investigators amended the trial protocol to allow patients in the dacarbazine control arm to get Yondelis at their doctor's discretion. J&J is also amending the trial to allow in patients with liposarcoma and leiomyosarcoma.
The company says it plans to release data from the study at an upcoming conference. According to ClinicalTrials.gov, though, the trial won't be completed until the end of 2015.
"We are particularly proud of this filing, as it represents our commitment to Yondelis and the people it may help," said Dr. Peter Lebowitz, the head of global oncology for Janssen. "The advanced soft tissue sarcoma treatment landscape has been relatively stagnant for decades and it's our hope that Yondelis will be a new treatment option for people living with this aggressive disease."
J&J licensed its rights to the drug outside of Japan and Europe, where PharmaMar holds the rights. The antitumor agent was derived from a sea squirt and is currently sold in 76 countries but not the U.S.
- here's the release