Scotland backs AZ’s Lynparza for first-line ovarian cancer maintenance

The Scottish Medicines Consortium (SMC) has backed routine funding of AstraZeneca and MSD’s Lynparza as a maintenance treatment after an initial round of chemotherapy for ovarian cancer.

The cost-effectiveness watchdog’s green light makes AZ/MSD’s PARP inhibitor the only drug in the class approved for this use in newly diagnosed BRCA-mutated, high-grade advanced ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum chemotherapy.

The SMC decision means Lynparza (olaparib) will now be an option for some of the approximately 600 women with newly diagnosed ovarian cancer in Scotland each year. Around 22% of ovarian cancer patients carry a BRCA mutation.

According to AZ, patients with newly diagnosed advanced ovarian cancer are the only ones in whom treatment has curative potential, but with current standard treatments more than two-thirds (70%) of cases relapse within three years.

Two thirds of ovarian cancer cases are diagnosed when the disease is more advanced, where the chances of survival are lower, and around 350 women die from the disease in Scotland each year.

Lynparza was approved by the EMA as a first-line maintenance therapy for BRCA-mutated ovarian cancer in June, on the back of the phase 3 SOLO-1 trial which showed Lynparza reduced the risk of disease progression or death by 70% versus placebo in patients who respond to chemo.

It has also been cleared for this use in the US and most recently in China, which gave the go-ahead last week.

Lynparza has also been recommended by NICE for first-line maintenance use in England, but in this case the drug is being made available with reimbursement from the Cancer Drugs Fund while additional evidence for its survival benefit is gathered. It has full NHS coverage for later-line therapy.

“Although the data are immature, we are hopeful that this treatment may also increase overall survival in the future,” said Professor Charlie Gourley of Edinburgh University, who led the UK arm of SOLO-1.

“It is now imperative that all women with ovarian cancer are tested for the BRCA mutation to give them the benefit of this therapy wherever possible,” he added. That’s a critical point, as charity Ovarian Cancer Action estimates that almost a third (29%) of women are missing out on genetic testing.

Lynparza is one of the stars of AZ’s fast-growing cancer drugs portfolio, bringing in almost $850 million in sales in the first nine months of the year and forecast to be a $2.5 billion product at its peak.

It is facing new competition in the PARP inhibitor class however, including from GlaxoSmithKline’s Zejula (niraparib) and Clovis Oncology’s Rubraca (rucaparib) in ovarian cancer and Pfizer’s Talzenna (talazoparib) in BRCA-positive breast cancer.