A BRCA mutation diagnosis comes with a lot of unfamiliar terms all at once — PARP inhibitor, maintenance therapy, germline testing. Olaparib, sold under the brand name Lynparza, is usually one of the first drug names a patient hears.
This article walks through what the drug does, who it is approved for, how it is dosed, and what side effects and precautions come with it. Every clinical fact and every trial number below is drawn directly from the FDA-approved prescribing information for Lynparza (label effective July 2025) — not from marketing copy or secondhand summaries. Drug approvals differ by country and are revised over time, so treat this as background reading, not a substitute for what your own oncologist tells you.
| Drug class | PARP inhibitor, a targeted therapy taken by mouth (not chemotherapy) |
| Brand name | Lynparza (developed by AstraZeneca and MSD) |
| Used for | Certain BRCA-mutated ovarian, breast, pancreatic and prostate cancers, and HRD-positive ovarian cancer when combined with bevacizumab |
| Tablet strengths | 100 mg and 150 mg film-coated tablets |
| Usual adult dose | 300 mg (two 150 mg tablets) twice a day, about 12 hours apart, with or without food. Always follow your own prescription. |
| Before starting | A validated test must confirm the right BRCA or HRD result. Prescription-only medicine. |
| Common side effects | Nausea, tiredness, anemia, vomiting, diarrhea, reduced appetite |
| Good to know | Not a cure — it is used as maintenance or add-on therapy alongside surgery, chemotherapy or hormone treatment. |
Olaparib is a PARP inhibitor — an oral drug that works by targeting how cancer cells repair their own DNA, rather than attacking dividing cells broadly the way chemotherapy does.
PARP Repairs small, single-strand breaks in DNA as they happen — routine maintenance every cell relies on. | BRCA1 and BRCA2 Handle the more serious double-strand breaks. A working copy of both genes is needed for this repair pathway. | What olaparib does Blocks PARP. In a cell that has already lost its BRCA repair pathway, unrepaired breaks accumulate until the cell cannot survive. |
A tumor with a harmful BRCA mutation — inherited or acquired — has already lost that second repair route and leans on PARP to get by. Olaparib removes that fallback. Healthy cells, which still have working BRCA genes, are far less affected. This selective vulnerability is called synthetic lethality, and it is the basis for every approval olaparib currently holds.
The table below reflects the current FDA-approved indications. Other countries may approve fewer, or slightly different, uses.
| Cancer | Who it is typically for | What olaparib does |
|---|---|---|
| Ovarian (including fallopian tube and primary peritoneal) | BRCA-mutated (germline or somatic) or HRD-positive advanced disease that responded to platinum chemotherapy; or BRCA-mutated disease that came back and responded to platinum | Maintenance therapy to keep the cancer from returning or growing |
| Breast | Inherited (germline) BRCA-mutated, HER2-negative breast cancer: high-risk early stage after chemotherapy, or metastatic | Lowers recurrence risk in early disease; slows progression in metastatic disease |
| Pancreatic | Germline BRCA-mutated metastatic pancreatic adenocarcinoma that has not progressed after at least 16 weeks of first-line platinum chemotherapy | Maintenance therapy to delay progression |
| Prostate | Metastatic castration-resistant prostate cancer with BRCA or other HRR gene mutations | Slows progression, alone or with abiraterone |
Ovarian cancer is where olaparib was first approved, and it remains the setting with the most FDA-reviewed trial data.
| NR vs 13.8 months | SOLO-1 · NCT01844986 Median progression-free survival, olaparib vs placebo, in the FDA review of this trial (hazard ratio 0.30; 95% CI 0.23–0.41; p<0.0001). "NR" means the median had not been reached at the time of analysis; overall survival data were not yet mature. |
| 19.1 vs 5.5 months | SOLO-2 · NCT01874353 Median progression-free survival, olaparib vs placebo (hazard ratio 0.30). Overall survival numerically favored olaparib — 51.7 vs 38.8 months — but the label notes this difference did not reach statistical significance (p=0.0537). |
| 37.2 vs 17.7 months | PAOLA-1 · NCT02477644 Median progression-free survival in patients with HRD-positive tumors, olaparib plus bevacizumab vs bevacizumab alone (hazard ratio 0.33). Overall survival also favored the combination: 75.2 vs 57.3 months. The label is specific that this benefit was concentrated in HRD-positive tumors — in patients whose tumors tested HRD-negative, adding olaparib made no measurable difference. |
| 86% vs 77% | OlympiA · NCT02032823 3-year invasive disease-free survival, olaparib vs placebo (hazard ratio 0.58). 3-year overall survival also favored olaparib: 93% vs 89% (hazard ratio 0.68). |
| 7.0 vs 4.2 months | OlympiAD · NCT02000622 Median progression-free survival by independent review, olaparib vs chemotherapy (hazard ratio 0.58). Response rate was higher with olaparib (52% vs 23%), though overall survival was similar in both arms (19.3 vs 17.1 months) and did not differ significantly. |
Pancreatic cancer remains one of the hardest cancers to treat, which is part of why this approval matters even with a modest effect size.
| 7.4 vs 3.8 months | POLO · NCT02184195 Median progression-free survival, olaparib vs placebo (hazard ratio 0.53). The FDA label is explicit that POLO did not demonstrate an overall survival benefit — median overall survival was nearly identical in both arms (19.0 vs 19.2 months). |
Men carry BRCA mutations too, and they turn up more often in advanced prostate cancer than most people expect. Olaparib is approved in metastatic castration-resistant prostate cancer (mCRPC) — disease that keeps progressing despite hormone-lowering treatment — through two separate routes on the label:
| 7.4 vs 3.6 months | PROfound, Cohort A · NCT02987543 Median radiographic progression-free survival in patients with BRCA1, BRCA2 or ATM mutations, olaparib vs enzalutamide or abiraterone (hazard ratio 0.34). Overall survival also favored olaparib: 19.1 vs 14.7 months (hazard ratio 0.69). |
| NR vs 8 months | PROpel, BRCA-mutated subgroup · NCT03732820 Median radiographic progression-free survival, olaparib plus abiraterone vs placebo plus abiraterone, specifically in the BRCA-mutated subgroup — the population this combination approval covers (hazard ratio 0.24). Overall survival also had not been reached in the olaparib arm versus 23 months with placebo (hazard ratio 0.30). |
Patients also continue androgen-deprivation therapy (a GnRH analog) or have had their testicles removed. Blood clots were reported more often in the prostate cancer trials, so this is one setting where your care team is likely to watch more closely for related symptoms.
Olaparib is never started on a hunch — a validated biomarker result is the gate for every approval it holds. In practice, that usually looks like this:
1. Ask about testing early Your oncologist can order a germline test (blood or saliva), a tumor test on biopsy or surgical tissue, or both. | 2. Get the report in writing It should name the specific gene (BRCA1, BRCA2 or another HRR gene) and classify the finding as pathogenic or likely pathogenic. |
3. See a genetic counselor A germline result also matters for children, siblings and other blood relatives, who may want testing of their own. | 4. Match the result to the label Your oncologist checks the cancer type, stage, prior treatment and biomarker against what olaparib is actually approved for. |
Check that the strength and total daily dose on the pharmacy label match what your oncologist last prescribed. Dose reductions for side effects, kidney function or drug interactions are common with olaparib, so the amount on a refill can legitimately change between visits — confirm rather than assume.
| Situation | Usual duration |
|---|---|
| Newly diagnosed advanced ovarian cancer | Up to two years, or longer if the doctor sees continued benefit |
| High-risk early breast cancer | One year |
| Recurrent ovarian, metastatic breast, metastatic pancreatic and prostate cancer | Until the disease progresses or side effects are no longer acceptable |
Most patients notice some of these, particularly in the first few weeks of treatment.
To report a suspected side effect involving a product we supplied, use our adverse event reporting page. You can also report directly to your national regulator or to the marketing authorization holder.
| Topic | What to know |
|---|---|
| Other medicines | Strong or moderate CYP3A inhibitors (some antifungals such as itraconazole, some antibiotics such as clarithromycin) can raise olaparib levels; strong or moderate CYP3A inducers (rifampicin, some anti-seizure drugs, St John's wort) can lower them. Tell your care team about everything you take, prescription or otherwise. Grapefruit and Seville oranges are typically avoided too. |
| Pregnancy | Olaparib can cause fetal harm. Women who could become pregnant should use effective contraception during treatment and for 6 months after the last dose. Men whose partner could become pregnant should use contraception during treatment and for 3 months after. |
| Breastfeeding | Not recommended during treatment, or for one month after the last dose. |
| Driving and work | Tiredness and dizziness are common enough that caution is warranted until you know how you personally respond. |
Olaparib is a prescription-only cancer medicine. Where it is registered and reimbursed, patients typically receive it through a hospital or specialty pharmacy. In many other countries, it may not be launched yet, approval timelines can cause delays, or the price is simply out of reach for a family without support.
Ikris Pharma Network is a pharmaceutical sourcing and supply company — we do not manufacture medicines. We help hospitals, pharmacies, importers and treating doctors reach hard-to-find oncology products through documented, regulated channels. Depending on the destination country, that can mean:
Whether a particular brand or an India-manufactured version can be supplied depends on the destination country's rules, the patient's prescription, and current availability. We confirm each case individually and never guess.
Olaparib (Lynparza) is a targeted tablet used for cancers linked to BRCA mutations or faulty DNA repair. Depending on the country, that includes certain ovarian, breast, pancreatic and prostate cancers, and it is prescribed only after a biomarker test confirms eligibility.
No. It is a targeted therapy called a PARP inhibitor. Chemotherapy damages fast-dividing cells throughout the body, while olaparib exploits a specific DNA-repair weakness in cancer cells with a BRCA mutation or similar deficiency. It can still cause side effects, and it is sometimes used after or alongside other cancer treatments.
No trial has described it as a cure. It has extended the time before cancer progresses in several settings, and in early breast cancer it lowers the chance of recurrence. How much benefit any one person gets depends on the cancer type, stage and biology — worth asking your oncologist directly what to expect in your case.
Sometimes. A few approvals rely on broader markers — HRD-positive ovarian cancer combined with bevacizumab, or a wider set of HRR gene mutations in prostate cancer. Outside those specific approvals, benefit has not been established, so olaparib should not be started without a supporting test result.
It depends on the cancer. In newly diagnosed advanced ovarian cancer, treatment usually runs up to two years; in early breast cancer, one year. In recurrent ovarian, metastatic breast, metastatic pancreatic and prostate cancer, it continues until the disease progresses or side effects become unacceptable.
Nausea, tiredness, anemia, vomiting, diarrhea and reduced appetite are the most frequently reported. Blood counts can fall, so regular testing is part of routine care. Rarer but serious risks include MDS/AML, lung inflammation, liver problems and blood clots, which is why warning symptoms are reported promptly.
All four are PARP inhibitors, but their FDA-approved uses, doses and side-effect profiles differ. Olaparib currently holds one of the broadest sets of approvals, spanning ovarian, breast, pancreatic and prostate cancer. The right choice depends on the cancer, the biomarker result, prior treatment and how well a patient tolerates the drug.
Yes. Men with BRCA-mutated metastatic castration-resistant prostate cancer can receive olaparib, and men with a germline BRCA mutation and HER2-negative breast cancer or pancreatic cancer may qualify under the same criteria that apply to women.
Tell your care team about every medicine and supplement you use. Certain antifungals and antibiotics can raise olaparib levels, while rifampicin, some anti-seizure drugs and St John's wort can lower them. Grapefruit and Seville oranges are typically avoided as well. Never start or stop a medicine without checking first.
Do not take a double dose. Per the FDA label, the next dose is taken at its usual scheduled time. If you are unsure, or you vomited shortly after taking a dose, call your oncology team rather than guessing.
Your doctor will follow imaging and relevant blood markers — such as CA-125 in ovarian cancer or PSA in prostate cancer — alongside how you feel. During maintenance treatment, "working" usually means the cancer stays quiet rather than shrinking further, which is why regular check-ups matter even when you feel well.
Often, yes — though it depends on the destination country's import rules, the prescription on file, and whether the medicine is already registered there. Ikris Pharma Network coordinates the documentation and logistics. Share your country and requirement, and we will tell you what is realistic.
Ikris Pharma Network is an international pharmaceutical services company with offices in Noida (India), Sofia (Bulgaria) and Hong Kong. We source, supply and distribute hard-to-access medicines, with a focus on oncology and rare diseases. Learn more on our company page, or explore other targeted cancer therapies, such as acalabrutinib for MCL, CLL and SLL.
This article is for general educational purposes and does not replace medical advice, diagnosis or treatment. Olaparib is a prescription-only medicine that must be started and monitored by a qualified oncologist. Do not start, stop or change any treatment based on this page. Approvals, doses and safety information vary by country and are updated over time, so always check the current product label and speak to your doctor. See our full disclaimer.
Every dosing, safety and efficacy figure in this article is drawn from a single primary source:
Lynparza (olaparib) Prescribing Information. AstraZeneca Pharmaceuticals LP, in collaboration with Merck & Co. (MSD). U.S. Food and Drug Administration — label version effective July 10, 2025, retrieved from the FDA's openFDA drug label database. Sections referenced: Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, and Clinical Studies (Section 14).
Section 14 of the label lists each trial by its ClinicalTrials.gov identifier, included above next to each result for anyone who wants to look up a trial directly: