TGA approval for new ovarian cancer therapy

AstraZeneca’s Lynparza (olaparib) tablets have been registered by the Therapeutic Goods Administration

This means clinicians can prescribe Lynparza tablets for eligible women at an earlier stage, after they complete just one line of chemotherapy, rather than waiting until the patient relapses.

Ovarian cancer still has the lowest survival rate of any women’s cancer in Australia. Almost 1,500 women are diagnosed annually, with just 46 per cent of women alive five years after diagnosis, and one woman dying of the disease every 10 hours.

The tablets are indicated for the maintenance treatment of adult patients with advanced BRCA-mutated (germline or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy.

BRCA mutation status should be determined by an experienced laboratory using a validated test method.

“Lynparza’s TGA registration is based on the global SOLO1 trial and provides women with BRCA1/2 mutated ovarian cancer with a first-line treatment option,” said Professor Clare Scott of the Peter MacCallum Cancer Centre, Royal Women’s and Melbourne Hospitals.

AstraZeneca Australia and New Zealand Country President Liz Chatwin said: “Lynparza’s new indication is a demonstration of AstraZeneca’s ongoing commitment to Australian women living with BRCA mutated ovarian cancer, and to ensuring all those who may benefit from Lynparza are able to access it earlier in their treatment cycle.”

Lynparza is a targeted therapy, which means it needs to be matched to genes or particular cancer type. It is designed to act on specific molecular targets to attack cancer cells.

 

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