LONDON: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca’s drug Truqap, in combination with Faslodex, for treating certain advanced breast cancer cases. The positive opinion is based on the CAPItello-291 Phase III trial results, which showed a 50% reduction in disease progression or death compared to Faslodex alone.
The trial, published in The New England Journal of Medicine, demonstrated a median progression-free survival of 7.3 months for the combination therapy versus 3.1 months for Faslodex alone. This recommendation could provide a new treatment option for nearly half of the patients with HR-positive, HER2-negative breast cancer, which is the most common subtype in Europe.
Experts highlight the urgent need for new treatments to delay disease progression in patients with advanced ER-positive breast cancer. Truqap plus Faslodex could extend the effectiveness of endocrine-based therapies, especially for those with PIK3CA, AKT1, or PTEN-alterations.
The safety profile of the combination therapy aligns with previous trials. With regulatory applications under review in China and other countries, and approvals already in Japan, the US, and several other countries, Truqap could soon be a global option for breast cancer treatment.
AstraZeneca’s Truqap approved in US for advanced breast cancer