
Jul 18 2025
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Everest Medicines Announces Taiwan FDA Has Accepted New Drug Application for Sacituzumab Govitecan in Second-Line Metastatic Triple-Negative Breast Cancer
Everest Medicines Limited, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Asia, announced today that the Taiwan FDA had accepted the submission of an NDA for sacituzumab govitecan in adult patients with Metastatic Triple-Negative Breast Cancer (TNBC) who have received two or more prior systemic therapies, at least one of which was for metastatic disease.
Source: Everest Medicines Limited
Triple-Negative Breast Cancer (TNBC) is a heterogeneous disease encompassing a variety of biomarkers or genomic signatures; it accounts for 12% of all breast cancers. Higher incidence of TNBC in African-Americans, younger women, and women with BRCA1 gene mutation TNBC is biologically more aggressive than other breast cancer subtypes with shorter disease-free survival and overall survival 1- and 2- year survival rates are 75% and 55%, respectively. Prognosis is poor in the advanced stages – median survival of 13.3 months following diagnosis of metastatic TNBC Cytotoxic chemotherapy is the mainstay treatment for TNBC. Anthracycline or taxane-based regimens in adjuvant settings Single or combination chemotherapies are used in 1L metastatic TNBC – paclitaxel, carboplatin, capecitabine+docetaxel, gemcitabine+paclitaxel; bevacizumab (EU only)+paclitaxel 2L and subsequent line mTNBC, single-agent chemotherapy – capecitabine/ gemcitabine/ eribulin/ taxane/ ixabepilone (US only) ± capecitabine.
- Basal-like and clinicopathologically defined TNBC (ER/ PR−, Her2 −) are not synonymous but have substantial “overlap.” TNBC accounts for ~12% of all breast cancers in the US.
However, the current Triple-Negative Breast Cancer (TNBC) treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (Talimogene Laherparepvec and Atezolizumab, Tumor-infiltrating lymphocytes, LY3023414 and Prexasertib, PMD-026, etc.) have 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 Triple-Negative Breast Cancer (TNBC) treatment. The key companies in the advanced development stage are Amgen, Iovance Biotherapeutics, Inc., Eli Lilly and Company, Phoenix Molecular Designs, etc.
Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook report on Triple-Negative Breast Cancer (TNBC) 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 2020 to 2030.
Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. 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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