AstraZeneca secured the FDA approval based on positive results from Phase 3 CAPItello-291 clinical trial that evaluated the Truqap plus Faslodex compared to placebo plus Faslodex, in 708 adults with inoperable or metastatic HR-positive, HER2- negative breast cancer
AstraZeneca has received the US Food and Drug Administration (FDA) approval for Truqap (capivasertib) in combination with Faslodex (fulvestrant) to treat a type of breast cancer.
Truqap is an adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3), currently in Phase 3 trials for the treatment of several subtypes of breast cancer.
Faslodex represents a hormonal treatment approach that helps to slow tumour growth by blocking and degrading the oestrogen receptor – a key driver of disease progression.
The combination is indicated for the treatment of adults with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer with PIK3CA, AKT1 or PTEN biomarker alterations.
Patients with progression on at least one endocrine-based regimen in the metastatic setting or seen recurrence within 12 months of completing adjuvant therapy are also eligible.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “The rapid US approval of Truqap reinforces the important role of the PI3K/AKT pathway in HR-positive breast cancer and the critical need to test patients at the time of diagnosis, as up to fifty per cent have tumours with these alterations.
“As a first-in-class medicine, this approval provides a critical new option for patients in the US with this specific type of disease and we look forward to bringing Truqap to the many breast cancer patients who can benefit across the globe.”
AstraZeneca secured the FDA approval based on positive results from the CAPItello-291, a Phase 3 double-blind, randomised clinical trial of the Truqap plus Faslodex combination.
The Phase 3 trial evaluated the Truqap plus Faslodex compared to placebo plus Faslodex, in 708 adults with inoperable or metastatic HR-positive, HER2-low or negative breast cancer.
It has dual primary endpoints of PFS in the overall patient population and in a population of patients whose tumours have qualifying alterations in the PI3K/AKT pathway.
In the Phase 3 study, Truqap plus Faslodex reduced 50% risk of disease progression or death in patients with PI3K/AKT biomarker alterations, compared to Faslodex alone.
Also, the CAPItello-291 trial showed a safety profile for the Truqap plus Faslodex, which was consistent with that observed in previous studies of the combination therapy.
Together with the drug combination, the US health regulator also approved a companion diagnostic (CDx) test to detect relevant alterations in the PIK3CA, AKT1 and PTEN biomarkers.
It has granted Priority Review for AstraZeneca’s regulatory submission under its Project Orbis initiative, which enables review of the products among other regulator partners.
Under the Project Orbis initiative, Truqap plus Faslodex will be reviewed by regulatory authorities in Australia, Brazil, Canada, Israel, Singapore, Switzerland and the UK.
Furthermore, the Truqap plus Faslodex combination is also currently under review in China, the European Union (EU), Japan and several other countries.