NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Thursday issued a final draft guidance recommending AstraZeneca's PARP inhibitor Lynparza (olaparib) as a treatment for HER2-negative locally advanced or metastatic breast cancer in patients with germline BRCA1 or BRCA2 mutations who have had prior chemotherapy and, for hormone receptor (HR)-positive patients, prior endocrine therapy.
NICE said it originally began reviewing Lynparza in this setting in 2018 but had to end its appraisal because the company "was unable to submit any evidence." The latest recommendation is based on new efficacy data from the Phase III OlympiAD trial, which AstraZeneca has submitted since NICE ended its original appraisal of Lynparza.
In OlympiAD, researchers compared Lynparza's activity against physician's choice of chemotherapy in approximately 300 breast cancer patients with germline BRCA1/2 mutations, regardless of HR status. Lynparza improved survival outcomes compared to chemo. Median progression-free survival was 7.03 months on Lynparza versus 4.17 months on chemo, and overall survival was 19.25 months and 17.12 months, respectively.
In the US, Lynparza has been commercially available in this same indication since January 2018.
NICE also conducted an indirect comparison of Lynparza and Pfizer's PARP inhibitor Talzenna (talazoparib), which was recommended in the UK last year for germline BRCA1/2-mutant, HER2-negative advanced or metastatic breast cancer. Experts concluded that the available evidence suggested Lynparza is "likely to work as well as [Talzenna]."
NICE's recommendation builds on the commercial deal the National Health Service negotiated with AstraZeneca in 2023. The list price for Lynparza is £2,317.50 ($2,848.22) per 56 pack of 150 mg tablets, but AstraZeneca is providing the drug to the NHS at an undisclosed discount. NICE further noted that a cost comparison between Lynparza and Talzenna suggested that Lynparza has lower costs than Talzenna.
In the UK, Lynparza is also recommended as a third-line treatment for BRCA1/2-mutant ovarian cancer and as a maintenance therapy for homologous recombination repair-deficient ovarian cancer. However, NICE previously concluded that the drug was not a cost-effective option for metastatic, hormone-relapsed prostate cancer patients with BRCA1/2 mutations.