Lynparza’s label expansion
On March 28, 2017, the FDA accepted for review AstraZeneca’s (AZN) new drug application (or NDA) seeking approval for Lynparza as a second-line maintenance therapy for BRCA-mutated ovarian cancer.
This application, which was granted a priority review by the FDA, is based on results obtained from the SOLO-2 trial and Study 19. AstraZeneca expects to launch Lynparza in tablet formulation for this indication by 3Q17.
On June 4, 2017, AstraZeneca announced positive results from its phase 3 trial, Olympia, which demonstrated the superiority of Lynparza over standard chemotherapy in reducing the risk of disease progression or death in patients suffering from BRCA-mutated breast cancer.
If AstraZeneca manages to expand Lynparza’s label beyond ovarian cancer, it may have a favorable impact on its share price as well as that of the Vanguard FTSE Europe ETF (VGK). AstraZeneca makes up about 0.32% of VGK’s total portfolio holdings.
The illustration above summarizes AstraZeneca’s research programs for Lynparza.
Future data readouts
AstraZeneca is currently exploring Lynparza as first-line maintenance therapy in ovarian cancer in the SOLO-1 trial. Data from this study should be available in the second half of 2017. The company is also exploring the drug in BRCA-mutated pancreatic cancer indication in the POLO trial.
In the Olympia trial, Lynparza is being evaluated in first-line BRCA-mutated breast cancer indication in an adjuvant setting.
AstraZeneca is aiming to expand Lynparza’s label beyond BRCA-mutation-driven cancers. The drug is being evaluated in the PROFOUND trial as a treatment option for prostate cancer.
To leverage opportunity in the entire ovarian cancer and breast cancer segments, AstraZeneca is exploring a combination regimen involving Lynparza with the multi-vascular endothelial growth factor receptor (or VEGFR) inhibitor, Cediranib.
The superiority of this combination therapy over Lynparza monotherapy based on progression-free survival was demonstrated by the mid-stage study data released in 2014. In the PAOLA trial, the company is studying the combination of Lynparza with Roche Holdings’ (RHHBY) Avastin in first-line metastatic ovarian cancer indication.
In the next article, we’ll discuss demand trends for AstraZeneca’s diabetes drug, Farxiga.