Now FoundationOne CDx Ovarian Cancer molecular oncotest is approved as a supplemental testing by the FDA when prescribing Lynparza — Olaparib. This targeted therapy is used as first-line maintenance treatment for metastatic ovarian cancer with BRCA 1/2 mutations.
FoundationOne CDx is a genomic test for all solid malignant tumors, which is done on tumor biopsy tissue. It allows to create a tumor mutation profile and helps the doctor to choose the most effective treatment for the patient.
Leading Doctors for Ovarian Cancer – Consultation Online
Foundation One Ovarian Cancer recognizes the germ, hereditary, and somatic (acquired) mutations of the BRCA1 and BRCA2 tumor genes in ovarian cancer. Genomic testing includes a detection of replacement (point), insertion / deletion (InDel mutations), and transcript number changes (CNAs) in selected 32 genes and alternatives. Foundation One CDx testing in women has an advantage over classical diagnostic methods looking for half of the required BRCA mutations, because other ones diagnose of BRCA1 / 2 in the germ line only.
Lynparza use in Europe and USA
In December 2018, Lynparza – a PARP inhibitor – was further approved by the FDA in the United States as first-line therapy for the treatment of advanced uterine epithelial cancer and primary peritoneal cancer. This first-line targeted therapy is prescribed after platinum-based chemotherapy with a full or partial response together with genomic testing for the presence of hereditary or somatic BRCA mutations (gBRCAm or sBRCAm), for example, using FoundationOne CDx Ovarian Cancer testing. Lynparza can also be used after three platinum-based chemotherapy and a negative response.
Also on June 18, 2019, the European Commission approved Lynparza as a first-line treatment for women with BRCA-mutated advanced ovarian cancer, as well as for cancer of the Fallopian tubes with FIGO stages III and IV and primary peritoneal cancer with a BRCA1/2-mutation. Lynparza is used after the first line of platinum-based chemotherapy with a full or partial response.