GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Trabectedin overview

Trabectedin (Yondelis) is an anti tumor agent of marine origin discovered in the caribbean tunicate, ecteinascidia turbinata. It is formulated as lyophilized powder for solution for injection for intravenous route of administration. Yondelis is indicated for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer. Yondelis is also indicated for the treatment of patients with metastatic liposarcoma. Yondelis is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

Trabectedin is under development for the treatment of mesenchymal chondrosarcoma, recurrent meningioma, uterine and ovarian carcinosarcoma, soft tissue sarcoma (first line), epithelial ovarian cancer, peritoneal cancer, fallopian tube cancer, chronic lymphocytic leukemia. It was also under development for malignant pleural mesothelioma, metastatic prostate cancer, HER2-breast cancer, synovial sarcoma, chronic lymphocytic Leukemia, meningioma, myxoid liposarcoma, dedifferentiated liposarcoma, round cell liposarcoma and malignant mesothelioma. It is a new molecular entity (NME).

Pharma Mar overview

Pharma Mar is a biopharmaceutical company. It discovers, develops and markets marine-derived drugs to treat cancer. The company’s marketed products include Yondelis (trabectedin), an antitumor agent indicated for the treatment of soft tissue sarcoma and relapsed ovarian cancer in combination with doxorubicin HCl liposome injection; Aplidin (plitidepsin), an anticancer agent for the treatment of multiple myeloma; and Zepzelca (lurbinectedin) for small cell lung cancer. It also develops RNAi candidates for the treatment of retina diseases. The company operates through its subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland, and the US. Pharma Mar is headquartered in Colmenar Viejo, Madrid, Spain.

For a complete picture of Trabectedin’s drug-specific PTSR and LoA scores, buy the report here.

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.