Drug for BRCA mutated ovarian cancer one step closer to Europe
24 Oct 2014
Olaparib, a drug for the maintenance treatment of BRCA-mutated ovarian cancer has received recommendation from European regulators. This affects women with "platinum-sensitive, relapsed high grade serous epithelial ovarian cancer" which responded to platinum chemotherapy.
Specific details of the recommendation
In particular, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorization of olaparib (trade name: Lynparza™) 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.
Phase 2 trial: progression free survival prolonged by 7 months
This was based on the results from Study 191, a Phase 2 clinical trial that 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 compared with placebo in patients with BRCA-mutated ovarian cancer: 11.2 months vs. 4.3 months.
The most common adverse events associated with olaparib monotherapy to date were generally mild to moderate and included nausea, vomiting, fatigue and anemia.
"If approved, olaparib could offer new hope to women with advanced ovarian cancer"
Harpal Kumar, Chief Executive, Cancer Research UK, said: “We’re delighted that olaparib has received a positive opinion from the CHMP, particularly given the early role Cancer Research UK scientists played in discovering and developing PARP inhibitors as a new generation of drugs that exploit the weaknesses cancer cells have in repairing damaged DNA. If approved, olaparib could offer new hope to women with advanced ovarian cancer and this illustrates how our partnerships with AstraZeneca are helping us to accelerate our efforts to beat cancer through new treatments for patients."
Next steps towards approval
The CHMP’s positive opinion on olaparib will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.
Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumor DNA repair pathway deficiencies to preferentially kill cancer cells. If approved, it will be the first PARP inhibitor available in these markets for the treatment of platinum sensitive relapsed BRCA-mutated high grade serous ovarian cancer.
Source: eCancer News