British drug major AstraZeneca Plc. (AZN.L,AZN) announced Friday that the U.S. Food and Drug Administration or FDA has approved its Truqap (capivasertib) in combination with Faslodex (fulvestrant) to treat patients with advanced hormone receptor or HR-positive breast cancer.
The Truqap in combination with Faslodex approval is for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN).
Concurrently with this approval, the FDA also approved a companion diagnostic test to detect relevant alterations (PIK3CA, AKT1 and PTEN).
Following the US approval, Astex Therapeutics is eligible to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the US as well as royalties on future sales. This is in line with the agreement between the two companies.
The approval was based on on the results from the CAPItello-291 Phase III trial which showed Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% versus Faslodex alone in the biomarker-altered population.
The company noted that eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.
Breast cancer is the most common cancer and HR-positive breast cancer is the most common subtype.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, 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."
Regulatory applications for Truqap in combination with Faslodex are also currently under review in China, the European Union, Japan and several other countries.
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