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Lynparza (olaparib)
Lynparza blocks the repair of DNA damage in cancer cells by inhibiting the enzyme PARP.
Lynparza (olaparib) is a small molecule Poly(ADP-Ribose) Polymerase Inhibitor developed by AstraZeneca, targeting Poly [ADP-ribose] polymerase 2. It was FDA-approved in 2014 for various cancer indications, including BRCA mutation-positive breast and ovarian cancers. Lynparza is patented and has no generic manufacturers. Key safety considerations include myelosuppression, nausea, and fatigue. It is a targeted therapy that works by blocking the repair of DNA damage in cancer cells.
At a glance
| Generic name | olaparib |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Poly(ADP-Ribose) Polymerase Inhibitor [EPC] |
| Target | Poly [ADP-ribose] polymerase 2 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2014 |
| Annual revenue | 2600 |
Mechanism of action
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular functions, such as DNA transcription and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer, both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA1/2, ATM, or other genes involved in the homologous recombination repair (HRR) of DNA damage and correlated with platinum response. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.
Approved indications
- BRCA mutation-positive and HER2-negative breast cancer
- Epithelial tumor of ovary
- Hormone refractory prostate cancer
- Human epidermal growth factor 2 negative carcinoma of breast
- Malignant tumor of ovary
- Malignant tumor of pancreas
- Malignant tumor of peritoneum
Common side effects
- Nausea
- Fatigue
- Anemia
- Vomiting
- Diarrhea
- Decreased appetite
- Headache
- Dysgeusia
- Cough
- Neutropenia
- Dyspnea
- Dizziness
Key clinical trials
- Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) (PHASE3)
- Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy (PHASE3)
- Platine, Avastin and OLAparib in 1st Line (PHASE3)
- Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (PHASE3)
- Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (PHASE3)
- Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer (PHASE2)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lynparza CI brief — competitive landscape report
- Lynparza updates RSS · CI watch RSS
- AstraZeneca portfolio CI