Tazemetostat hydrobromide by Ipsen for Rhabdomyosarcoma: Likelihood of Approval

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.

Tazemetostat hydrobromide overview

Tazemetostat hydrobromide (Tazverik) is an anti-neoplastic agent. It is formulated as film coated tablets for oral route of administration. Tazverik is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options.

Tazemetostat hydrobromide is under development for the treatment of pancreatic cancer, colorectal cancer, recurrent or metastatic head and neck squamous-cell carcinoma, marginal zone lymphoma, non-Hodgkin lymphoma, mantle cell lymphoma, metastatic castration-resistant prostate cancer, b-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, chordoma, primary mediastinal B-cell lymphoma (EZH2), peripheral T-cell lymphomas (PTCL), other relapsed or refractory solid tumors such as INI1-negative tumors including malignant rhabdoid tumor (MRT), rhabdoid tumor of the kidney (RTK), atypical teratoid / rhabdoid tumor (ATRT), epithelioid malignant peripheral nerve sheath tumor, neuroblastoma, extraskeletal myxoid chondrosarcoma, myoepithelial carcinoma, hepatocellular carcinoma, relapsed or refractory mesothelioma (pleural, peritoneal, pericardial, tunica vaginalis), renal medullary carcinoma, urothelial carcinoma, small-cell lung cancer and 3 unspecified indications. The drug candidate is administered orally. It is a selective small molecule inhibitor of protein methyltransferase EZH2. It was also under development for chronic myeloid leukaemia, endometrial cancer, ovarian cancer, peritoneal cancer and uterine cancer. It was also under development for the treatment of synovial sarcoma, rhabdomyosarcoma, hematological tumor, Non-Hodgkin lymphoma, solid tumor and lymphoma, squamous non-small cell lung cancer.

Ipsen overview

Ipsen is a global specialty biopharmaceutical company engaged in the manufacturing and distribution of drugs for the treatment of cancer, rare diseases, and neurological diseases, including specialty pharmaceutical products. The company develops and commercializes novel medicines for cancer, neuroscience and rare diseases and offers products to treat gastrointestinal disorders, and neurodegenerative pathologies. Ipsen sells its drugs through a network of distributors and directly to hospitals in a few countries. The company operates its research and development facilities in Paris-Saclay, France; Oxford, the UK; and Cambridge, the US. The company offers products in Europe, North America, and rest of the world. Ipsen is headquartered in Paris, France.

For a complete picture of Tazemetostat hydrobromide’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.