Sumitomo Pharma's TP-1287 granted FDA Orphan Drug and Rare Pediatric Disease Designations for Ewing sarcoma
Sumitomo Pharma Oncology, Inc. has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for TP-1287, an oral CDK9 inhibitor that is being investigated for the treatment of Ewing sarcoma, a rare type of cancer. The FDA has also granted TP-1287 rare pediatric disease designation. TP-1287 is currently being evaluated in an ongoing phase 1 trial (NCT03604783) for its effectiveness in patients with metastatic or progressive solid tumors that are unresponsive to other available therapies.
Publish Date: 10-04-2023 Source: Sumitomo Pharma Oncology
Ewing sarcoma (ES), also known as a peripheral primitive neuroectodermal tumor, is a type of tumor that develops from a specific type of cell in either bone or soft tissue. In Ewing sarcoma, the chromosomal areas involved are the long arms (q) of chromosomes 11 and 22 (11q24-22q12). These pieces break off and trade places. In most cases, this results in the abnormal fusion of two genes, usually the EWS and FLI genes.
- Around 200 to 250 children and adolescents are diagnosed with a tumor from the Ewing family of tumors in the United States each year, with two-thirds of them being long-term survivors (more than five years). The annual incidence of Ewing sarcoma is 2.93 cases per 100,000 children.
However, the current Ewing sarcoma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Vigil, Eribulin mesylate, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.
In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Ewing sarcoma (ES) treatment. The key companies in the advanced development stage are Gradalis, Inc., Eisai Inc., etc..
Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Ewing sarcoma (ES) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.
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Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.
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