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EMA committee recommends AstraZeneca’s ovarian cancer drug Lynparza

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending AstraZeneca's marketing authorization of ovarian cancer drug Lynparza (olaparib) as monotherapy.

Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumor DNA repair pathway deficiencies to kill cancer cells.

The drug is indicated to patients who are in response (complete or partial) to platinum-based chemotherapy.

AstraZeneca executive vice-president of Global Medicines Development and chief medical officer Dr Briggs Morrison said the company is happy that the CHMP has recommended Lynparza as a first-in-class treatment option for women with BRCA-mutated ovarian cancer and they look forward to the European Commission’s decision once it completes its review.

"We are committed to investigating the full potential of olaparib and have a number of studies underway in multiple tumour types including breast and gastric cancer," Morrison said.

The CHMP positive opinion was based on the results from Study 191, a Phase II clinical trial that assessed the efficacy and safety of olaparib compared to placebo in platinum sensitive relapsed high grade serous ovarian cancer patients.

The trial showed that olaparib maintenance therapy has prolonged progression free survival (PFS) compared with placebo in patients with BRCA-mutated ovarian cancer.

The most common adverse events related with olaparib monotherapy to date were generally mild to moderate and included nausea, vomiting, fatigue and anaemia.

AstraZeneca chief executive Cancer Research UK Harpal Kumar said the company is happy 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," Kumar said.