FDA Approval: Olaparib (Lynparza) for Ovarian Cancer

A drug that needed a test to go with it

On December 19, 2014, the FDA approved olaparib capsules, sold as Lynparza. The same day, it approved a genetic test to decide who should get them.

That pairing was the point. The approved use was for advanced ovarian cancer in people with a harmful inherited BRCA mutation, who had already had three or more lines of chemotherapy. Without the test result, the label does not apply.

Why a broken repair gene creates a target

Cells fix broken DNA all the time. They have more than one way to do it.

BRCA1 and BRCA2 are genes for one of those repair routes. When a person inherits a faulty copy, that route works poorly. Cells then lean harder on the backup routes.

PARP is an enzyme that runs one of those backups. Olaparib blocks PARP. In a normal cell that is survivable, because the BRCA route still works. In a tumor cell that has already lost the BRCA route, losing the backup too is often fatal.

Scientists call this synthetic lethality: two faults that each cell can survive alone, but not together. It is one of the cleanest examples of what targeted therapy is trying to do.

The evidence behind the 2014 approval

The label rests on a single-arm study. Single-arm means everyone got the drug and there was no comparison group.

A total of 137 people with measurable, BRCA-mutated ovarian cancer took part. All had already had three or more lines of chemotherapy. The median age was 58. The dose was 400 mg twice a day, taken as eight 50 mg capsules. That capsule regimen is from the original study. Tablets are used now, so match your prescription rather than this figure.

This is the amount written on the 2014 label, printed here as history. Anyone taking olaparib now should go by the prescription their own cancer team wrote, which may differ.

The objective response rate was 34%, with a 95% confidence interval of 26% to 42%. Of those, 2% were complete responses and 32% were partial. The median duration of response was 7.9 months.

This was an accelerated approval, granted on response rate and response duration rather than on how long people lived. The label said outright that continued approval could depend on confirming the benefit later.

Where the drug went next

The label did not stay still. In September 2017 the FDA gave regular approval to olaparib tablets as maintenance treatment for recurrent ovarian, fallopian tube, or primary peritoneal cancer in people responding to platinum chemotherapy.

That approval did not require a BRCA mutation. NCI described the move as broadening the use of PARP inhibitors, and noted that the capsules were being discontinued in favor of tablets. Maintenance means continuing a drug after chemotherapy has already shrunk the cancer, to hold that ground longer.

Why ovarian cancer is usually found late

NCI is blunt about this. Ovarian, fallopian tube and primary peritoneal cancer often causes no early signs, and when symptoms do show up the cancer is often advanced.

The symptoms it lists are ordinary ones:

• Pain, swelling, or a feeling of pressure in the belly or pelvis.
• Needing to pass urine urgently or often.
• Trouble eating, or feeling full quickly.
• A lump in the pelvic area.
• Gas, bloating, or constipation.

Any single one of those is usually something harmless. The pattern worth acting on is different: symptoms that are new for you, that happen most days, and that have lasted more than two or three weeks. Take that pattern to a clinician and say how long it has been going on.

There is no routine screening program for ovarian cancer in people at average risk. NCI notes that pelvic exams, vaginal ultrasound and the CA-125 blood test all have low predictive value in women without special risk factors.

Who should think about genetics

NCI reports that around 20% of ovarian cancers run in families, and that most of those are linked to BRCA1 or BRCA2. Lynch syndrome is another route.

Raise genetic counseling with your team if ovarian cancer, early breast cancer, or a cluster of related cancers has appeared in your close relatives. The answer changes prevention options as well as treatment ones. Our page on ovarian cancer covers how the diagnosis is worked up, and biomarker testing explains the difference between an inherited test and a tumor test.

The survival picture

The year-ahead counts come from the American Cancer Society: about 21,010 new ovarian cancer diagnoses in the United States in 2026, and about 12,450 deaths, published on SEER's ovarian page. The survival picture is NCI's own SEER work: five-year relative survival across all stages was 52.0% for people diagnosed 2016 to 2022, with a median age at diagnosis of 63.

Stage drives most of that. Only 22% of cases are found while still confined to the ovary. Fully 54% are already distant at diagnosis.

These are population figures from past years of treatment. They summarize a group. They cannot tell any individual what will happen, and they do not reflect newer options such as PARP inhibitors used earlier in care.

What this approval cannot tell you

• The 2014 label covers a narrow group: inherited BRCA mutation, advanced disease, three or more prior lines of chemotherapy.
• A response rate of 34% means most people in the study did not have a measurable response.
• Accelerated approval means the evidence cleared an early bar, not that longer survival was demonstrated.
• A tumor BRCA result and an inherited BRCA result are different tests answering different questions.
• Olaparib carries real side effects, including anemia, nausea and fatigue, and a small risk of secondary blood cancers noted in its labeling.

Sources

• FDA approval package for LYNPARZA (olaparib), NDA 206162, December 19, 2014
• FDA prescribing information for LYNPARZA (olaparib) capsules, 2014
• NCI: FDA Approves Olaparib as Maintenance Therapy for Recurrent Ovarian Cancer
• NCI PDQ: Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (Health Professional Version)
• SEER Cancer Stat Facts: Ovarian Cancer

How this page was made

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

Cancer Explained is published by the National Cancer Information Foundation. It is not medical advice and does not suggest a test or treatment.

See an error, old source, or unclear wording? Tell us.