FDA expands use of AZ/Merck’s Lynparza in the US

AstraZeneca and Merck & Co’s Lynparza will be available to a wider range of patients in the US after regulators expanded the PARP inhibitor’s list of approved uses.

The US Food and Drug Administration has cleared a new use for the drug as a maintenance treatment for recurrent, epithelial ovarian, fallopian tube or primary peritoneal adult cancer who are in response to platinum-based chemotherapy, regardless of BRCA status.

The regulator also approved Lynparza (olaparib) tablets with an easier dosing regimen of two tablets twice daily than that of Lynparza capsules, of which patients had to take eight twice daily.

Lynparza tablets are also now indicated for the use in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy, following conversion from accelerated approval.

The approval is "welcome news for US patients with ovarian cancer, who are now able to benefit from treatment with olaparib irrespective of their BRCA-mutation status," said Eric Pujade-Lauraine, head of the women cancers and clinical research department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, AP-HP and principal investigator of the SOLO-2 trial.

SOLO-2 confirmed the benefit of Lynparza in germline BRCA-mutated patients, showing a 70 percent reduced risk of disease progression or death and improved progression-free survival (PFS) to 19.1 versus 5.5 months for placebo.

The news came just weeks after AstraZeneca and Merck & Co entered a global strategic oncology collaboration to co-develop and co-commercialise Lynparza and experimental medicine selumetinib, a MEK inhibitor, for multiple cancer types.