Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Lynparza

Lynparza 100 mg film-coated tablets Lynparza 150 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-130536 · Präparat HOS-096931

In patients with BRCAm platinum-sensitive relapsed ovarian cancer who had received at least two prior lines of platinum chemotherapy and received study treatment until disease progression (SOLO2 study, with olaparib treatment ≥2 years in 45% of patients), the incidence of MDS/AML was 8% in patients receiving olaparib and 4% in patients receiving placebo at a follow-up of 5 years. In the olaparib arm, 9 out of 16 MDS/AML cases occurred after discontinuation of olaparib during the survival follow-up. The incidence of MDS/AML was observed in the context of extended overall survival in the olaparib arm and late onset of MDS/AML. The risk of MDS/AML remains low in the first-line setting when olaparib maintenance treatment is given after one line of platinum chemotherapy for a duration of 2 years (1.5%) in SOLO1 study at 7 year follow up and 1.1% in PAOLA-1 study at 5 year follow up. For risk mitigation and management (see section 4.4).

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