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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.
AstraZeneca's EGFR-inhibitor has now demonstrated an 'overwhelming' disease-free survival and CNS recurrence benefit, but overall survival benefit remains unknown.
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.
NICE is reversing its earlier negative recommendation for the lung cancer drug after AstraZeneca agreed to provide it at a discount.
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.
The companies will collaborate on a trial evaluating the HER3-targeted antibody drug conjugate patritumab deruxtecan in combiantion with AstraZeneca's Tagrisso.
The companies will jointly develop and commercialize DS-1062 worldwide, sharing in the development costs and the profits, but Daiichi Sankyo will maintain exclusive rights in Japan.
The approval will make Merck and AstraZeneca's Lynparza available to patients in the EU who have not progressed after 16 weeks on platinum-based chemotherapy.