Hot on the heels of an approval in Europe AstraZeneca’s first-in-class PARP inhibitor Lynparza (olaparib) has now also been given a green light in the US.
The US Food and Drug Administration has approved Lynparza as the first monotherapy for patients with BRCA-mutated advanced ovarian cancer, but only for those who have received three or more prior lines of chemotherapy.
The drug has been pushed through the FDA’s Accelerated Approval programme because of promising mid-stage data on response rates (34%) and duration of this response (7.9 months). However, AZ will have to supply data from ongoing Phase III trials confirming the drug’s clinical benefit in order to convert the conditional approval into a full one.
Lynparza, which works by exploiting tumour DNA repair pathway deficiencies to selectively kill cancer cells, is the first PARP inhibitor to be approved for patients with BRCA-mutated advanced ovarian cancer, as detected the companion diagnostic test, BRACAnalysis CDx.
Ursula Matulonis, Associate Professor of Medicine, Harvard Medical School and Director of the Gynaecological Oncology Programme at the Dana-Farber Cancer Institute, Boston, said the long-term survival rate in patients with advanced ovarian cancer is 10% to 30% and that the FDA’s nod for the drug “is a significant milestone” for patients as there are only limited treatment options available to those with the BRCA mutation.