Janssen submits YONDELIS NDA for treatment of advanced soft tissue sarcoma

Dossier for YONDELIS for advanced soft-tissue sarcoma received by the US FDA

• The results from a Phase III randomized, open label study are the basis for the submission of a registration dossier for YONDELIS® by Janssen Research & Development, LLC for the treatment of advanced soft tissue sarcoma in the US

• In the U.S., more than 12,000 people will be diagnosed with soft tissue sarcoma and 4,700 deaths due to this disease are expected to occur in 2014

• The U.S. expanded access program will now be open to eligible patients with previously treated advanced soft tissue sarcoma, including those with liposarcoma and leiomyosarcoma to be treated with YONDELIS®

PharmaMar announces that Janssen Research & Development, LLC (Janssen) has submitted a New Drug Application (NDA) for YONDELIS® (trabectedin) to the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.

In its press release, Janssen also announced plans to amend the protocol for the Phase III randomized, open-label study ET743-SAR-3007, on which the NDA submission is based. The protocol will be revised to offer patients who were randomized to the dacarbazine comparator arm the option of receiving trabectedin treatment at their physician's discretion. This trial is evaluating the safety and efficacy of trabectedin versus dacarbazine for the treatment of advanced liposarcoma and leiomyosarcoma, the most common types of STS in adults, in more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. Results of the study will be presented at a future date.

At the same time, Janssen will be revising the current U.S. trabectedin expanded access program (EAP), ET743-SAR-3002, to allow entry of eligible patients with liposarcoma and leiomyosarcoma. The program was developed to provide trabectedin to eligible patients with previously treated STS who cannot be expected to benefit from limited currently available therapeutic options. Patient enrolment will be extended to those with liposarcoma or leiomyosarcoma once the protocol amendment is implemented at participating sites.

Source: Pharmamar