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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.
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.
Through a licensing agreement with Drexel, Rain will support the ongoing development of RAD52 inhibitors for patients with homologous recombination deficient cancers.
Over the last six months the agency approved 21 cancer treatments for molecularly defined indications compared to 12 during the same period last year and 20 during all of 2019.
With studies showing BRCA-mutated patients have a greater magnitude of benefit, oncologists grapple with complex treatment decisions in BRCA mutation-free cases.