Clinical Trials

* On November 24, 2014, Janssen Research & Development announced plans to amend the protocol for the Phase 3 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. In related news, 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 enrollment will be extended to those with liposarcoma or leiomyosarcoma as soon as the protocol amendment is implemented at participating sites. Interested patients should discuss the option of accessing trabectedin through the EAP with their physician to understand if this is an appropriate option for them.
* On February 17, 2014, PharmaMar has announced that the \"National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology\" on uterine neoplasms highly recommends the inclusion of patients with uterine leiomyosarcoma in clinical trials with Yondelis®, which has proven to be effective (overall survival: 13.9 months) in patients for which standard lines of treatment have failed. The NCCN is a not-for-profit alliance of 23 of the world\'s leading cancer centres devoted to research, and education and patient care. Its main objectives are to improve the quality, effectiveness and efficiency of cancer care so that patients can live better lives.

* On December 18, 2013, PharmaMar has announced that Janssen Research & Development has completed patient recruitment for SAR-3007,a registration Phase III study of Yondelis® for the treatment of L- type sarcomas. In Europe and other non-US countries, Yondelis® is approved for the treatment ofpatients with advanced soft tissue sarcoma after failure of anthracyclines and ifosfamide or patients who are not suitable for treatment with these agents.The drug is also approved, in combination with pegylated liposomal doxorubicin, for the treatment of platinum-sensitive recurrent ovarian cancer.