LYNPARZA
Lynparza (olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of specific ovarian and breast cancers. It serves as a maintenance therapy for adult patients with advanced or recurrent ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy. The drug is also used for the adjuvant and metastatic treatment of HER2-negative breast cancers harboring germline BRCA mutations. Patient selection for these therapies is determined by FDA-approved companion diagnostics that identify BRCA mutations or homologous recombination deficiency status.
How LYNPARZA Works
Olaparib inhibits PARP enzymes, including PARP1, PARP2, and PARP3, which are involved in normal cellular functions such as DNA transcription and repair. The drug blocks PARP enzymatic activity and increases the formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death. This cytotoxic activity is most effective in tumor cells with deficiencies in homologous recombination repair genes, such as BRCA1/2 or ATM. In certain models, the drug also contributes to the regulation of androgen receptor activity.
Details
- Status
- Prescription
- First Approved
- 2014-12-19
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
LYNPARZA Approval History
What LYNPARZA Treats
4 indicationsLYNPARZA is approved for 4 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
- Breast Cancer
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LYNPARZA FDA Label Details
ProIndications & Usage
FDA Label (PDF)Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. • in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary pe...
LYNPARZA Patents & Exclusivity
Patents (231 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.