AstraZeneca Gains FDA Approval for LYNPARZA™ Capsules

AstraZeneca plc (LSE:AZN,NYSE:AZN) announced that the US Food and Drug Administration (FDA) has approved LYNPARZA™ capsules as the first monotherapy for patients who have “deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer” and have been previously treated with three or more lines of chemotherapy.

LYNPARZA™ is also called olaparib.

As quoted in the press release:

Olaparib has been approved under the FDA’s Accelerated Approval programme, based on existing objective response rate and duration of response data. Continued approval for this indication is contingent upon verification of clinical benefit in ongoing confirmatory Phase III trials.

Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, as detected by an FDA approved companion diagnostic test, BRACAnalysis CDx™.

Click here to read the full AstraZeneca plc (LSE:AZN,NYSE:AZN) press release.