The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) for approval within the European Union. This recommendation is intended for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer, specifically those with PIK3CA, AKT1, or PTEN alterations after previous endocrine-based regimen failures.

The positive opinion from CHMP is anchored in the promising results from the CAPItello-291 Phase III clinical trial, as published in The New England Journal of Medicine. The trial demonstrated that Truqap in combination with Faslodex significantly reduced the risk of disease progression or death by 50% compared to Faslodex alone. Patients with tumors harboring specific genetic alterations showed a median progression-free survival of 7.3 months versus 3.1 months for those treated solely with Faslodex.

Dr. Mafalda Oliveira, a Senior Consultant at the Department of Medical Oncology at Vall d’Hebron University Hospital and Senior Clinical Investigator at VHIO’s Breast Cancer Group in Barcelona, stressed the urgent need for new approaches to extend the effectiveness of endocrine therapies. “With this combination demonstrating a fifty percent reduction in disease progression or death in patients with tumors harboring PIK3CA, AKT1, or PTEN-alterations in the CAPItello-291 trial, this positive recommendation marks an important step in providing a much-needed new treatment option for approximately half of patients in this setting with these specific tumor biomarkers,” Dr. Oliveira stated.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, highlighted the impact of the recommendation. “Today’s news reinforces the practice-changing potential of Truqap in combination with Faslodex to extend the effectiveness of endocrine-based treatment approaches for patients who experience tumor progression on, or resistance to widely used endocrine-based therapies,” said Galbraith.

The safety profile of Truqap plus Faslodex in the CAPItello-291 trial was consistent with previous studies, supporting its use in clinical settings. With regulatory reviews underway in China and other regions, and approvals already secured in Japan, the US, and several other countries, this treatment stands poised to become a global standard for this challenging cancer subtype.

  AKT1, AstraZeneca, breast cancer treatment, CHMP recommendation, European Union, Faslodex, oncology research, PIK3CA, PTEN, Truqap