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News and reporting on BRCA biomarkers.
The decision is based on data from the PAOLA-1 trial, which focused on patients with tumors that have homologous repair recombination deficiency.
CHMP recommended approval only in patients with BRCA1/2 mutations, while the FDA approved olaparib in those with mutations in additional HRR genes.
Trial data, however, raised doubt about Lynparza's benefit in metastatic castration-resistant prostate cancer patients with non-BRCA1/2 HRR gene mutations.
After five years, nearly half the Lynparza-treated patients in the SOLO-1 trial remained disease-free, compared with one-fifth of those who received placebo.
Adult participants will have access to saliva-based testing from Invitae for the Screen Project, which aims to find clinically actionable BRCA1/2 mutations.
The company will use the proceeds to advance several biomarker-driven targeted drugs in its pipeline, including a recently licensed MDM2 inhibitor.
The nationwide study will enroll prostate cancer patients who do and don't meet current guidelines and assess how access to genetic information impacts their care.
Results of the randomized Phase III BROCADE trial, recently published in The Lancet Oncology, suggested a benefit of veliparib combined with platinum-based chemotherapy.
Senaparib is currently being studied in a Phase II trial as a monotherapy for BRCA-mutated ovarian cancer patients who have received at least two prior lines of therapy.
Patients on the combo regimen had similar outcomes to those on monotherapy, but researchers said that the benefit seen in certain groups should be explored in randomized trials.