Sacituzumab govitecan (SG) has been approved by FDA in April 2021 for pre-treated metastatic triple-negative breast cancer (mTNBC), following the ASCENT trial results.#We set up an ambispective bicentric cohort study to assess the real-world effectiveness and safety of SG in patients with ...
Immunomedics awarded fast track designation by FDA for sacituzumab govitecan for non-small cell lung cancer therapy [media release]. 5 Jan 2015. https://www.immunomedics.com/. Orphan drug product desgination [database on the Internet]. 2020. https://www.fda.gov/. Immunomedics. Immunomedics ...
The FDA’s decision was supported by efficacy data from the single-arm phase 1/2 IMMU-132-01 trial (NCT01631552), which showed that sacituzumab govitecan induced durable responses in the 108 patients with mTNBC who were treated with the ADC. The overall response rate was 33.3% (95% CI,...
An accelerated approval was granted by the FDA to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. ...
OncLive®: What is the significance of the FDA approval of sacituzumab govitecan in patients with HR-positive, HER2-negative breast cancer? Traina: It is always significant when we have another highly effective agent FDA approved for our patients who are under tre...
Sacituzumab govitecan (SG) has been approved by FDA in April 2021 for pre-treated metastatic triple-negative breast cancer (mTNBC), following the ASCENT trial results.#We set up an ambispective bicentric cohort study to assess the real-world effectiveness and safety of SG in patients with mTN...
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for sacituzumab govitecan. Trodelvy(sacituzumab govitecan-hziy) - Gilead Sciences, Inc. Formulation typeStrength ...
Then, one year later, SG was approved by the FDA for patients with locally advanced or metastatic urothelial cancer who previously received chemotherapy and immunotherapy [49]. The first-in-human SG trial demonstrated promising anti-tumor efficacy with acceptable tolerability in Trop-2-positive, ...
For patients with EGFR-mutated non–small cell lung cancer, sacituzumab tirumotecan was given the breakthrough drug designation by the FDA. Sacituzumab tirumotecan (SKB264) has been granted breakthrough therapy designation by the FDA for patients with previously treated EGFR-mutatedadvanced or...
Sacituzumab govitecan (SG) has been approved by FDA in April 2021 for pre-treated metastatic triple-negative breast cancer (mTNBC), following the ASCENT tr... A De Moura,D Loirat,S Vaillant,... - 《Breast Cancer》 被引量: 0发表: 2024年 Sacituzumab Govitecan: A Review in Unresectable...