Lynparza for the maintenance treatment of BRCA-mutated Platinum sensitive relapsed ovarian cancer, a positive CHMP opinion in the EU
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending the marketing authorisation of Lynparza ( Olaparib ) as monotherapy for the maintenance treatment of adult patients with Platinum sensitive relapsed BRCA-mutated ( germline and/or somatic ) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response ( complete or partial ) to Platinum-based chemotherapy.
Olaparib is an innovative, investigational, potential first-in-class oral poly ADP-ribose polymerase ( PARP ) inhibitor that exploits tumour DNA repair pathways deficiencies to selectively induce cancer cell death.
The positive CHMP opinion was based on the results from Study 19, a Phase II clinical trial that has evaluated the efficacy and safety of Olaparib compared to placebo in Platinum sensitive relapsed high grade serous ovarian cancer patients.
The study showed that Olaparib maintenance therapy significantly prolonged progression free survival ( PFS ) compared with placebo in patients with BRCA-mutated ovarian cancer ( median PFS 11.2 months vs 4.3 months; PFS HR=0.18; 95% CI 0.10–0.31; p less than 0.0001 ).
The most common adverse events associated with Olaparib monotherapy to date were generally mild to moderate and included nausea, vomiting, fatigue and anaemia.
In Europe, ovarian cancer is the fifth most commonly diagnosed cancer in women and the sixth leading cause of cancer death among women, mainly because it is often diagnosed late and has an extremely poor prognosis.
Women with BRCA1 or BRCA2 mutations have an increased risk of developing ovarian cancer; the lifetime risk for ovarian cancer is up to 40% in individuals who harbour these mutations. ( Xagena )
Source: AstraZeneca, 2014