TOKYO - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on February 20, 2024, for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic to identify patients eligible for AstraZeneca K.K.'s AKT inhibitor, Truqap tablets (generic name: capivasertib), in combination with Faslodex (generic name: fulvestrant) for patients with advanced unresectable or recurrent HR-positive, HER2-negative breast cancer with specific PIK3CA, AKT1 or PTEN alterations, which was approved by the MHLW on March 26, 2024.

'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. Osamu Okuda.

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. AstraZeneca K.K. obtained approval from the MHLW on March 26, 2024.

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 AstraZeneca K.K. has manufacturing and marketing approval.

About FoundationOne CDx Cancer Genomic Profile

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

Contact:

Hideki Sato

Tel: +81-3-3273-0881

Email: pr@chugai-pharm.co.jp

Takayuki Sakurai

Tel: +81-3-3273-0554

Email: ir@chugai-pharm.co.jp

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