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News and reporting on BRCA biomarkers.
Researchers found that cancer patients with BRCA2 mutations respond particularly well to checkpoint inhibitors compared to those with BRCA1 mutations.
Regulators approved the PARP inhibitor as a monotherapy for BRCA1/2-mutated mCRPC and together with Avastin for advanced, HRD-positive ovarian cancer.
The recently launched BRCA Care program may increase test access in six countries, though it cannot ensure access to downstream interventions based on results.
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.