The EC marketing authorisation was based on results from the Phase 3 ASCENT study of Trodelvy in people with metastatic triple-negative breast cancer
The EC approval was based on results from Phase 3 ASCENT trial. (Credit: Sébastien Bertrand/Wikipedia.)
Gilead Sciences has received the European Commission (EC) marketing authorisation for Trodelvy (sacituzumab govitecan) to treat a type of triple-negative breast cancer (TNBC).
The drug was indicated as a monotherapy for adults with metastatic TNBC, who received two or more prior systemic therapies, at least one of them for advanced disease.
Trodelvy is an anti-topoisomerase antibody-drug conjugate that targets Trop-2 receptor, a protein excessively expressed in different types of epithelial tumours.
High expression of Trop-2 receptor is often linked to poor survival and relapse.
The drug was approved in countries including Australia, Canada, Great Britain, the European Union (EU), Switzerland and the US, in second-line metastatic TNBC.
Also, it is under regulatory review in Singapore and China, with applications submitted by Everest Medicines.
Trodelvy was also recently included in the updated ESMO Clinical Practice Guidelines as a preferred treatment option for metastatic TNBC after taxanes.
Gilead Sciences chief medical officer Merdad Parsey said: “At Gilead, we push boundaries to deliver transformative science and novel treatment options that address urgent medical needs.
“We understand how difficult metastatic TNBC is to treat and we’re proud that Trodelvy can now offer a second-line treatment option with the potential to bring longer life to people living with this aggressive disease.”
The EC approval was supported by results from ASCENT, a global, open-label, randomised Phase 3 study of Trodelvy in more than 500 patients across 230 study locations.
In the study, treatment using Trodelvy reduced the risk of death by 49% and improved median overall survival (OS) compared to physician’s choice of chemotherapy.
It also showed a statistically significant and clinically meaningful reduction in the risk of death or disease worsening of 57% and improved median progression free survival (PFS)
The most common adverse reactions include neutropenia, leukopenia, diarrhoea, anaemia, febrile neutropenia, fatigue, hypophosphatemia, nausea and vomiting.
Furthermore, Trodelvy comes with a boxed warning for severe or life-threatening neutropenia and severe diarrhoea, prescription use in the US.