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NICE Recommends Lynparza for BRCA1/2-Mutant Ovarian Cancer After Two Rounds of Chemotherapy

NEW YORK – The UK National Institute for Health and Care Excellence (NICE) on Wednesday recommended Merck and AstraZeneca's PARP inhibitor Lynparza (olaparib) as a maintenance therapy for relapsed platinum-sensitive ovarian, fallopian tube, or peritoneal cancer patients in England whose cancers harbor BRCA1 or BRCA2 mutations and who have received two prior courses of platinum-based chemotherapy.

In a final draft guidance, which NICE expects to publish on June 28, barring any appeals, the agency said Lynparza's cost-effectiveness shows it to be an acceptable use of National Health Service funds. The list price for a 28-day supply of Lynparza tablets is £4,635 ($5,769). However, the NHS struck a deal with the drug sponsors to provide Lynparza at an undisclosed discount.

The PARP inhibitor was already available in England through the Cancer Drugs Fund to this patient population after three rounds of chemotherapy based on an earlier NICE recommendation. The latest recommendation expands the PARP inhibitor's use to patients after just two rounds of platinum-based chemo.

NICE based its recommendation on the results of the Phase III SOLO-2 trial, in which Lynparza significantly delayed disease progression and improved overall survival in BRCA1/2-mutated ovarian cancer patients following the second round of chemotherapy.

The US Food and Drug Administration approved Lynparza for platinum-sensitive, BRCA1/2-mutated advanced ovarian cancer as maintenance therapy after first-line platinum-based chemotherapy in 2018 along with Myriad Genetics' BRACAnalysis CDx. The European Commission also approved Lynparza for advanced ovarian cancer patients with BRCA1/2 mutations after first-line chemotherapy in 2019.