Olaparib is the first poly (ADP-ribose) polymerase, PARP, inhibitor with broad domestic indications, covering ovarian cancer, fallopian tube cancer, peritoneal cancer, prostate cancer, and breast cancer.
Accordinig to AstraZeneca's annual report, Olaparib (Lynparza) is approved in 101 countries as maintenance therapy for platinum-sensitive relapsed ovarian cancer and first-line BRCAm ovarian cancer. It is approved in 100 countries in combination with bevacizumab for HRD-positive advanced ovarian cancer. For breast cancer, it is approved in 101 countries for gBRCAm, HER2-negative early-stage disease, and in 86 countries for metastatic settings. The drug is approved in 99 countries for gBRCAm metastatic pancreatic cancer. For prostate cancer (mCRPC), it is approved in 101 countries for HRR gene mutations (BRCAm only in certain countries) and in 90 countries in combination with abiraterone for first-line treatment. Additionally, it is approved in 31 countries as maintenance therapy for advanced or recurrent endometrial cancer that is pMMR.
Lynparza remains the first-in-class PARP inhibitor across four tumor types as measured by total prescription volume, achieving 10% growth in 2024 versus 2023. It is the only PARP inhibitor to improve survival in early breast cancer. Updated results from the OlympiA Phase III trial demonstrated that Lynparza provided sustained, clinically meaningful improvements in overall survival, invasive disease-free survival, and distant disease-free survival at six years for patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer. Lynparza was recently approved in China for these patients.
Sales of Olaparib (Lynparza)
Lynparza showed a consistent upward sales trajectory over the analyzed period. From 2016, sales in the US increased tenfold by 2024, reaching their peak at $1,332 million. Europe's sales also expanded significantly, growing from $81 million in 2016 to $832 million by 2024, indicating a strong market presence akin to US growth trends. Emerging Markets and Rest of World demonstrated more modest but steady growth. Emerging Markets rose from $7 million to $655 million, highlighting increasing demand in these regions.
Global sales for 2023Q4-2024Q3 have exceeded $2.8 billion and are still growing at a rate of 8.4%.
Excellent efficacy with strong guideline recommendations
In clinical trials across multiple cancers, both as monotherapy and combination therapy, it significantly improved patients' median PFS and median OS; multiple authoritative guidelines both domestic and international strongly recommend Olaparib.
Excellent safety profile
Adverse reactions caused by Olaparib treatment are usually mild to moderate (CTCAE grade 1 or 2), and typically do not require treatment discontinuation. Since its launch, no countries have issued any safety warnings, black box warnings, or market withdrawal notices.
