FDA approves Olapa's first-line maintenance treatment for BRCA mutation in advanced ovarian cancer

December 19, 2018, AstraZeneca and Mercado jointly announced that the U.SFood and
Drug(http://Regulatory Authority (
FDA(http://) has approved Olapa's use of harmful or suspected harmful reproductive systems or Adult patients with advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with somatic cell BRCA mutation (gBRCAm or sBRCAm) who have reached full or partial remission after receiving first-line platinum chemotherapyabout OlapariOlapari is a first-class PARP inhibitor and the first targeted
treatment drug(http://that could potentially target cancer cells with DNA damage response (DDR) pathway defects such as BRCA mutationsInhibiting PARP by using Olapari will make DNA single-strand fracture impossible to repair, while the replication fork stalls and collapses, eventually leading to dna double-stranded rupture and cancer cell deathOlapari is conducting atrial(http:// for a range of DDR-defective and DDR-dependent tumors Olapari became the first PARP inhibitor to be approved for first-line maintenance therapy for advanced ovarian cancer with BRCA mutation This approval is based on positive results from the critical Phase III SOLO-1 test trial results confirmed that in patients with advanced stage ovarian cancer with BRCA mutations that achieved full or partial remission after platinum chemotherapy, Olapari reduced the risk of disease progression or death by 70% compared to the placebo group (HR 0.30 (95% CI 0.23-0.41), p 0.0001) Previous trials were consistent the SOLO-1 trial SOLO-1 is a Phase III randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy and safety of olapali tablets (300 mg/twice a day) as a single-drug maintenance therapy compared to placebos for patients with advanced stage of BRCA mutation undergoing first-line platinum chemotherapy trials were randomized in 391 patients with harmful or suspected harmful reproductive line or brca1 or BRCA2 mutations in body cells who achieved full or partial remission after receiving platinum chemotherapy Patients were randomly (2:1) treated with orwitha, or placebo, for two years or until the disease progressed For patients with partial remission after two years, it is up to the researchers to decide whether they will be allowed to continue treatment The primary endpoint is progression-free survival, and the key secondary endpoints include the time to the second progression or death of the disease, the time to the first follow-up treatment, and the total survival in the SOLO-1 trial, after a median 41-month follow-up, the Olapali group did not reach the median phase of progressionless (PFS), compared with 13.8 months in the placebo group In the Olapari group, 60 percent of patients had no progress over three years, compared with 27 percent in the placebo group