AstraZeneca and MSD’s Lynparza is a step closer to being cleared in Europe as maintenance therapy for some patients with ovarian cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use is backing approval of the drug as maintenance therapy in women with platinum-sensitive, relapsed, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
The recommendation for the PARP inhibitor is not linked to patients' BRCA status, the firms noted.
The decision is based on two randomised trials, SOLO-2 and Study 19, which showed Lynparza (olaparib) reduced the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo, by 70 percent and 65 percent, respectively.
“The data show that Lynparza provides long-term disease control, delaying the need for further chemotherapy for this broader group of women with platinum-sensitive relapsed ovarian cancer, irrespective of their BRCA status,” said AZ’ chief medical officer Sean Bohen.
“It also offers a well-characterised safety and tolerability profile, which is critical to help enable patients to stay on treatment.”
The side effects most frequently observed in clinical trials in patients receiving Lynparza monotherapy (≥10 percent) were nausea, vomiting, diarrhoea, dyspepsia, fatigue, headache, dysgeusia, decreased appetite, dizziness and anaemia.
Ovarian cancer is a serious and life-threatening condition causing more than 4,000 deaths in the UK each year. Up to 21 percent with the most aggressive form of ovarian cancer have the genetic BRCA mutation.
The drug, a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells, is already approved in the EU and US for the treatment of women with BRCAm ovarian cancer.