Roche's FoundationOne CDx Approved in Japan as Companion Diagnostic for AstraZeneca's Lynparza in BRCA-Mutated Ovarian Cancer

Swiss pharmaceutical giant Roche(Roche)Chugai Pharmaceutical, a Japanese pharmaceutical company under Roche's holding(Chugai)Recently announced, the Japanese Ministry of Health, Labour and Welfare (MHLW) has been approved for expansionFoundationOne® CDx Cancer Genomic Profile(hereinafter referred to as “F1CDx”, cancer genome analysis testing) as AstraZeneca’s anti-tumor drugPARPInhibitorLynparza(Chinese brand name: Lynparza, generic name:olaparib, olaparib tablets) forBRCAA Companion Diagnostic Kit for Maintenance Therapy in Patients with Mutated Advanced Ovarian Cancer After First-Line Chemotherapy.

It is worth noting that,F1CDxis approved in Japan for tumor detectionBRCAThe first companion diagnostic kit for mutations, capable of detecting germline (hereditary) and somatic (acquired) variantsBRCAMutation. This approval will allow physicians to adoptF1CDxTestingBRCA1/2Gene mutations, identifying those who may benefit fromLynparzaBenefits of Maintenance TherapyBRCAPatients with advanced ovarian cancer harboring mutations.

In Japan,LynparzaThis year6Month19Daily AcquisitionMHLWApproval of a New Indication forBRCAMaintenance Therapy for Patients with Mutated Ovarian Cancer After First-Line Chemotherapy. Under the global strategic oncology collaboration between AstraZeneca and Merck & Co., the two companies are jointly commercializing in JapanLynparza。

F1CDxis a cancer diagnostics and therapeutics company under RocheFoundation MedicineA next-generation sequencing product developed based on in vitro diagnostic equipment, utilizing tumor tissue isolated from patientsDNA, detect and analyze up to324substitutions, insertions, and deletions in individual genes, selected gene rearrangements, and including microsatellite instability (MSI) and tumor mutational burden (TMB) including genomic labels (genomic signature）。

F1CDxis a breakthrough companion diagnostic product, launched in2017Year11Approved in the United States at the end of the monthFDAApproval; this approval is hailed as a major milestone in the field of precision medicine.F1CDxIt enables the simultaneous detection of multiple clinically validated genetic mutations approved by regulatory authorities, surpassing the previous "one drug, one test" model.

In Japan,F1CDxThis year6Approved for the first time at the end of the month, this is the first next-generation sequencing product based on pan-tumor companion diagnostics approved in Japan. As a comprehensive auxiliary diagnostic tool, this kit has been approved in Japan to date for15Companion diagnostics for molecularly targeted drugs.

Lynparzais an anti-tumor drug from AstraZeneca, a first-in-class, oral poly-ADPRNA polymerase (PARP) inhibitors, which can utilize tumorsDNATissue Repair (DDR) pathway defects preferentially kill cancer cells, and this mode of action confersLynparzaTreatment ExistsDNAThe potential of a broad spectrum of tumors with defective damage repair.

Lynparzais the first globally listedPARPInhibitor, at2014Year12First U.S. Approval in [Month]FDAApproved. To date, the drug has been approved globally60Approved in multiple countries for maintenance treatment of platinum-sensitive recurrent ovarian cancer (regardlessBRCAstatus). The drug has been approved in the United States, the European Union, Japan, and several other countries as first-line maintenance therapy for patients whose disease has responded to platinum-based chemotherapy.BRCAMutation (BRCAm) advanced ovarian cancer. In addition, in countries including the United States and Japan40It has also been approved in multiple countries for use in patients with germline mutations who have previously received chemotherapy.BRCAm HER2Negative metastatic breast cancer; in the EU, this indication includes locally advanced breast cancer. Currently,LynparzaThe treatment of ovarian cancer, breast cancer, and pancreatic cancer is under review in other jurisdictions.

AstraZeneca and Merck & Co., Inc. on2017Year7Monthly Achievement of Global Strategic Cooperation in Oncology for Joint Development and CommercializationLynparzaand another typeMEKInhibitorselumetinibTreatment of various types of tumors. InPARPCategory of inhibitors,LynparzaPossessing the most extensive and advanced clinical trial development programs. Currently, both parties are collaborating to investigateLynparzaTherapeutic potential as monotherapy and combination therapy across a broad spectrum of tumor types.

In the Chinese market,Lynparza(Lynparza) at2018Year8Approved in [Month] for maintenance treatment of platinum-sensitive recurrent ovarian cancer.LynparzaIt is the first targeted therapy approved for the treatment of ovarian cancer in the Chinese market, marking the entry of China’s ovarian cancer treatment intoPARPThe Era of Inhibitors.

Original Source:Chugai Obtains Approval for the Expanded Use of FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic for Lynparza