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Olaparib: first global approval
1Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand, dru@adis.com.
Abstract:
Olaparib (Lynparza™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by AstraZeneca for the treatment of solid tumours. The primary indication that olaparib is being developed for is BRCA mutation-positive ovarian cancer. A capsule formulation of the drug has received approval for use in this setting in the EU and USA, and a tablet formulation is in global phase III trials (including in the USA, EU, Australia, Brazil, Canada, China, Israel, Japan, Russia and South Korea). In addition, phase III trials in breast, gastric and pancreatic cancer are underway/planned, and phase I/II investigation is being conducted in other malignancies, including prostate cancer, non-small cell lung cancer, Ewing's sarcoma and advanced cancer. This article summarizes the milestones in the development of olaparib leading to this first approval for ovarian cancer.
Insights
Olaparib, a poly (ADP-ribose) polymerase inhibitor, is approved for BRCA-positive ovarian cancer. Further trials are exploring its efficacy in breast, gastric, pancreatic, and other solid tumors.
Area of Science:
- Oncology
- Pharmacology
Background:
- Olaparib (Lynparza™) is an oral poly (ADP-ribose) polymerase (PARP) inhibitor.
- It is developed by AstraZeneca for treating solid tumors, with a primary focus on BRCA mutation-positive ovarian cancer.
Purpose of the Study:
- To summarize the development milestones of olaparib.
- To highlight its first approval for ovarian cancer treatment.
Main Methods:
- Review of olaparib's development pathway.
- Summary of clinical trial phases and global reach.
Main Results:
- Olaparib capsule formulation approved in the EU and USA for BRCA-positive ovarian cancer.
- Tablet formulation is in global phase III trials across multiple countries.
- Phase III trials are ongoing/planned for breast, gastric, and pancreatic cancers.
- Phase I/II investigations are underway for prostate cancer, non-small cell lung cancer, Ewing's sarcoma, and advanced cancers.
Conclusions:
- Olaparib represents a significant advancement in targeted cancer therapy.
- Its development trajectory shows potential for broad application in various solid tumors.
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