An important move was made today by the European Medicines Agency (EMA) as it licensed a drug against severe breast cancer.
The drug was licensed by the US Food and Drug Administration in April. (FDA).
As it became known today, Coreper has recommended to the European Commission to license the medicinal product with the active substance sacituzumab govitecan.
Experts note that this is a first-line drug for the treatment of patients with incurable (can not be removed by surgery) or metastatic triple-negative breast cancer.
Triple-negative breast cancer is an aggressive type of breast cancer that does not have the usual receptors to which other cancer drugs act..
So far, chemotherapy is the standard treatment for patients with metastatic triple-negative breast cancer.. Ενώ σύμφωνα με επιστημονικές μελέτες μόνο το 10 to 15% patients respond to this treatment and the time without exacerbation of their disease is only 2 to 3 months. Hence, there is a need for new treatments that improve the outlook for patients.
The active substance of the drug combines a humanized antibody (protein type), designed to recognize and bind to the Trop-2 receptor with a type of antineoplastic agent called a topoisomerase I inhibitor. This inhibits the growth and spread of cancer.
The Committee for Medicinal Products for Human Use (CHMP) examines the application for a marketing authorization - under fast procedures - to enable patients to access this medicine more quickly.
What the studies showed
The CHMP bases its recommendation on single-phase data 3, polycentric, open, randomized clinical trial. The study investigated the safety and effectiveness of Trodelvy in 529 patients with locally advanced or metastatic triple-negative breast cancer (mTNBC). All enrolled patients had recurrence after at least two previous breast cancer chemotherapy treatments. Participants were randomized (1: 1) to take Sakituzumab govitecan 10 mg / kg as an intravenous infusion on days 1 and 8 circles 21 days or treatment of the doctor's choice (eribulin, vinorelbine, gemcitabine or capecitabine).
The drug prolonged overall survival (i.e.. How long do patients live?) by approximately 5 months (11,8 months for sacituzumab govitecan versus 6,9 months for treatment of the doctor's choice) and survival without evolution (that is, how long patients live without their disease getting worse ) by approximately 3 months (4,8 months for sacituzumab govitecan compared to 1,7 months for treatment of the doctor's choice).
The most common side effects of Trodelvy in clinical trials have included diarrhea., motion sickness, neutropenia, fatigue, alopecia, anemia, puke, constipation, decreased appetite, cough and abdominal pain.
The CHMP opinion is an intermediate step in Trodelvy's path to patient access. The scientists' results will be sent to the European Commission for a marketing authorization decision across the EU. Once a marketing authorization has been granted, Price and refund decisions will be made at the level of each Member State, taking into account the possible role / use of this drug in the national health system of this country.
Source: eleftherostypos.gr
