Lynparza on cusp of approval for advanced ovarian cancer

Breast cancer drug Lynparza (olaparib) is poised for EU approval for the first-line treatment of a certain type of metastatic ovarian cancer.

Lynparza received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the treatment of germline BRCA-mutated HER2-negative metastatic ovarian cancer. A positive opinion leads to recommendation for approval.

This would mean that Lynparza becomes the first PARP inhibitor approved in Europe for patients with this particular gene mutation who have responded to an initial round of chempotherapy, and is the third EU approval for the medicine.

As well as the potential benefits for this cohort of patients, this spells potentially huge financial news for Merck & Co and AstraZeneca, who developed the medicine, with share prices already rising.

The CHMP’s positive opinion was based on data from a phase 3 SOLO-1 trial that showed Lynparza reduced the risk of disease progression or death by 70% versus placebo following response to platinum-based chemotherapy.

Of those patients receiving Lynparza, 60.4% remained progression-free at 36 months compared to 26.9% of women in the placebo group.

Dave Fredrickson, executive vice president, oncology, AstraZeneca, said: “There remains a significant unmet need in the treatment of advanced ovarian cancer as 70% of women globally relapse within the first three years after their initial treatment.

“The results of SOLO-1 demonstrate the potential of using Lynparza earlier in the treatment pathway as a maintenance therapy, and reinforce the importance of identifying a patient’s BRCA mutation status as soon as they are diagnosed.”

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, MSD Research Laboratories, said Lynparza demonstrated a significant progression-free survival benefit as maintenance treatment for this group of patients.

In December, the US Food and Drug Administration (FDA) approved the drug in a new first-line maintenance therapy indication for adults with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

Lynparza is approved in 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status.

It is also approved in the US, countries in the EU and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy; in the EU this includes locally advanced breast cancer.