'We are very pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for capivasertib, a cancer agent for three alterations (PIK3CA, AKT1 and PTEN) in breast cancer. By using this test as a companion diagnostic, approximately half of patients1,2,3 with advanced HR-positive, HER2-negative breast cancer will be able to consider a more appropriate treatment option. We will continue to contribute to the advancement of personalized healthcare based on the patient's genetic mutation status by expanding companion diagnostics,' said Chugai's President and CEO, Dr.
This approval enables the detection of PIK3CA, AKT1 and PTEN alterations using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use capivasertib in combination with faslodex for advanced HR-positive, HER2-negative breast cancer patients with tumors harbouring these alterations. The efficacy and safety of the combination therapy of capivasertib and fulvestrant in this specific form of breast cancer was evaluated in the global phase III CAPItello-291 study4.
As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of Comprehensive Genome Profile.
Fulvestrant is the generic name of the breast cancer agent 'FASLODEX' for which
About FoundationOne CDx Cancer Genomic Profile
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