Trabectedin is under clinical development by Pharma Mar and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Trabectedin’s likelihood of approval (LoA) and phase transition for Ovarian Cancer took place on 27 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Trabectedin Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
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, malignant pleural mesothelioma. It was also under development for metastatic prostate cancer, HER2-breast cancer, synovial sarcoma, chronic lymphocytic Leukemia, meningioma and malignant mesothelioma. It is a new molecular entity (NME).
Pharma Mar overview
Pharma Mar 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. Pharma Mar offers in vitro diagnostic products used for detection of virus and bacteria in respiratory infections and human papilloma virus genotypes, among others. Pharma Mar also offers kits used for diagnosis of SARS-CoV-2, influenza A and B and respiratory syncytial virus. Its development pipeline includes PM14 for solid tumors, among others. It also develops RNAi candidates for the treatment of retina diseases. The company has subsidiaries in Germany, Italy, France, Switzerland, the UK, and the US, among others. Pharma Mar is headquartered in Madrid, Spain.
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