The median time to response in participants was 2.0 months (range, 1.6 to 13.5), the median duration of response was 7.7 months (95% confidence interval [CI], 4.9 to 10.8), the median progression free survival was 5.5 months, and the median overall survival was 13.0 months. Of the participants that achieved an objective response to sacituzumab govitecan-hziy, 55.6% maintained their response for six or more months and 16.7% maintained their response for twelve or more months.Sacituzumab govitecan-hziy was granted accelerated approval along with priority review, breakthrough therapy, and fast track designations. The U.S. Food and Drug Administration (FDA) granted approval of Trodelvy to Immunomedics, Inc.In April 2021, the FDA granted regular approval to sacituzumab govitecan for people with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Efficacy and safety were evaluated in a multicenter, open-label, randomized trial (ASCENT; NCT02574455) conducted in 529 participants with unresectable locally advanced or mTNBC who had relapsed after at least two prior chemotherapies, one of which could be in the neoadjuvant or adjuvant setting, if progression occurred within twelve months.
Throughout the cycle the donor is monitored often by a physician using blood tests and ultrasound exams to determine the donors reaction to the hormones and the progress of follicle growth. Once the doctor decides the follicles are mature, they will establish the date and time for the egg retrieval procedure. Approximately 36 hours before retrieval, the donor must administer one last injection of HCG hormone to ensure that her eggs are ready to be harvested. The egg retrieval itself is a minimally invasive surgical procedure lasting 20–30 minutes, performed under sedation by an anaesthetist, to ensure the donor is kept completely pain free. Egg donors may also be advised to take a pain-relieving medicine one hour before egg collection, to ensure minimum discomfort after the procedure. A small ultrasound-guided needle is inserted through the vagina to aspirate the follicles in both ovaries, which extracts the eggs. After resting in a recovery room for an hour or two, the donor is released. Most donors resume regular activities by the next day. Results
In the United States, egg donor cycles have a success rate of over 60%. (See statistics at http://www.sart.org.) When a "fresh cycle" is followed by a "frozen cycle", the success rate with donor eggs is approximately 80%. With egg donation, women who are past their reproductive years or menopause can still become pregnant.