AZ’s ovarian cancer drug Lynparza recommended in Europe

A novel PARP inhibitor has received a positive opinion for treating ovarian cancer from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The committee has recommended marketing authorisation be granted for Lynparza (olaparib) from AstraZeneca (AZ) and now awaits a decision from the European Commission (EC) on whether it can be used in the European Union.

Olaparib is an investigational oral poly (ADP-ribose) polymerase (PARP) inhibitor that exploits deficiencies in the repair pathway of cancer cells to selectively induce cancer cell death and is recommended for maintenance therapy in women with platinum-sensitive relapsed BRCA-mutated (BRCAm) high-grade serous epithelial ovarian cancer who respond to platinum-based chemotherapy.

The drug was written off by AZ at one point, but was saved for further development at the insistence of the company’s scientists, who found it could help this specific sub-group of patients. The CHMP’s approval brings it a step closer to patients and keeps AZ’s hopes for a strong new revenue stream alive.

“Approximately 4,000 women in the UK die of ovarian cancer every year. The high grade serous subtype is the most common and most aggressive form, and survival rates are low compared to other cancers,” explained Jonathan Ledermann, Professor of Medical Oncology at University College London Cancer Institute and primary investigator of the olaparib clinical trials.

“Olaparib is a targeted therapy that has been shown to significantly lengthen the time until tumour relapse compared to placebo in patients with high grade serous cancers and a mutation of the BRCA gene.”

The CHMP’s opinion was based on results from AZ’s phase II trial of 265 patients, including a sub-analysis of olaparib in serous ovarian cancer patients both with and without the BRCAm.

Overall the data showed that olaparib maintenance therapy significantly prolonged progression-free survival to 11.2 months in patients with BRCAm ovarian cancer, compared to 4.3 months in patients taking placebo.

In addition, despite the introduction of an active anticancer treatment between courses of chemotherapy, quality of life was not reduced when compared to placebo. The phase III trial SOLO2 is ongoing and aims to confirm the phase II results.

Lisa Anson, president, AZ UK and Ireland affirmed that the company was working closely with health watchdog NICE and the NHS to ensure that patients in the UK would benefit from the treatment should it be approved by the EC.

Although not a cure, olaparib significantly prolongs remission in relapsed BRCAm, platinum sensitive, high-grade serous ovarian cancer.

Ovarian cancer is the fifth most common cancer among women in the UK and of those diagnosed, 14 per cent will carry a BRCA gene germline mutation. This figure increases to 17 per cent among those with high grade serous ovarian cancer. The current standard of care for ovarian cancer is chemotherapy and often surgery. While the majority respond to initial treatment, as many as 70 per cent have a recurrence within three years of diagnosis. The goal of treatment is therefore to extend the intervals between each subsequent relapse.

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