New drug approved in EU as treatment for ovarian cancer
New drug approved in EU as treatment for ovarian cancer
18 Dec 2014The European Commission has approved the use of olaparib (Lynparza) capsules as the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.
A validated diagnostic test will be used for the identification of the eligible patients, coming from all 28 EU member states as well as Norway, Iceland and Liechtenstein.
The drug exploits tumor DNA to kill cancer cells
Olaparib belongs to a category of agents known as "poly ADP-ribose polymerase inhibitors" (PARP inhibitors). It exploits tumor DNA properties to preferentially kill cancer cells.
It is the first PARP inhibitor to be approved for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer.
Significantly prolonged progression free survival with olaparib
The approval of olaparib was based on data from a Phase 2 clinical trial evaluating its efficacy and safety compared to placebo in platinum-sensitive relapsed high grade serous ovarian cancer patients. The study showed that patients treated with olaparib showed a significantly prolonged progression free survival of 11.2 months compared to 4.3 months in patients taking the placebo.
Mild side-effects
The most common adverse events associated with olaparib monotherapy to date were generally mild to moderate and included nausea, vomiting, fatigue and anemia.
Source: eCancer News