Lynparza approved for use beyond ovarian cancer

FDA accepts Mayne Pharma’s NDA of fungal infection treatment
Credit: Hurst Photo

Lynparza has become the first and only PARP inhibitor approved for use beyond ovarian cancer after the US FDA gave it the green light, according to AstraZeneca and Merck.

The approval was based on data from the randomised, open-label, Phase III OlympiAD trial which investigated Lynparza versus physician’s choice of chemotherapy.

In the trial, Lynparza significantly prolonged progression-free survival compared with chemotherapy, and reduced the risk of disease progression or death by 42%.

This is the third indication approved for Lynparza in the US, where it has been used to treat nearly 4,000 advanced ovarian cancer patients.

Lynparza has the broadest clinical development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to deliver Lynparza as quickly as possible to more patients across multiple settings, including breast, ovarian, prostate and pancreatic cancers.

Under its oncology collaboration with Merck – announced in July 2017 – AstraZeneca is potentially eligible for more than $6 billion of future Sustainable and Ongoing Externalisation Revenue in the form of sales-related and approval-related payments in addition to option payments until 2019.

Following this new approval for Lynparza, AstraZeneca will receive $70 million in Sustainable and Ongoing Externalisation Revenue.