For women with advanced or recurrent ovarian cancer

LYNPARZA may help give you more time progression free

LYNPARZA is an alternative to the watch-and-wait approach

Discover the difference between a watch-and-wait approach or active maintenance approach with LYNPARZA

After you’ve responded to chemotherapy, your health care provider can either choose to monitor the cancer with a watch-and-wait approach or continue treating the cancer with an active maintenance approach, like treatment with LYNPARZA.

Discover the difference between these 2 approaches

Researchers studied these 2 approaches after different rounds of chemotherapy.

LYNPARZA is the only treatment of its kind to receive FDA approval for women with advanced ovarian cancer and a BRCA mutation after they’ve completed the first line of platinum-based chemotherapy. LYNPARZA was tested against placebo, which is a pill that doesn’t contain any active medication. Placebo is similar to the watch-and-wait approach in that it does not treat the cancer. Below, you’ll find several studies that tested LYNPARZA after previous lines of platinum-based chemotherapy.

After the first line of chemotherapy

After the second line of chemotherapy

 

In women with a BRCA mutation

 

In women with a BRCA mutation

LYNPARZA SOLO-1 Study Design

STUDY DESIGN

SOLO-1 studied 391 women with a BRCA mutation and advanced ovarian cancer who responded to platinum-based chemotherapy. 260 women were given LYNPARZA and 131 were given placebo. A placebo is a pill that doesn't contain any active medication.

RESULTS

Doctors monitored all women in the study for a median* time of nearly 3.5 years (41 months). Some women saw their cancer grow or return. The study is still ongoing, but the results at the time the data were assessed are shown below.

70% less risk

LYNPARZA lowered the risk of progression.

LYNPARZA reduced the risk of cancer growing, spreading, or getting worse by 70% compared with placebo.

61% progression free

61% of women taking LYNPARZA did not see their cancer grow or return (158 women), compared with 27% of women taking placebo (35 women).

SAFETY

The most common adverse reactions in this study included tiredness or weakness, anemia, a low count of white blood cells, low levels of blood platelets, nausea, vomiting, abdominal pain, diarrhea, indigestion, constipation, mouth sores, sinus issues, urinary tract infection, loss of appetite, shortness of breath, changes in the way food tastes, and dizziness. Other adverse reactions included an increase in creatinine, a low count of white blood cells, swelling, allergies, skin rash, and increase in size of red blood cells. Because of an adverse reaction, 52% of women interrupted treatment with LYNPARZA and 17% interrupted treatment with placebo; 28% of women had their LYNPARZA doses reduced and 3% had their placebo doses reduced; and 12% of women stopped treatment with LYNPARZA and 2% stopped treatment with placebo. These are not the only side effects associated with LYNPARZA.

*The median is the middle number in a list of numbers arranged from lowest to highest.

LYNPARZA SOLO-2 Study Design

STUDY DESIGN

LYNPARZA was studied in 295 women with an inherited BRCA mutation and advanced ovarian cancer that came back and responded to platinum-based chemotherapy. 196 women were given 2 LYNPARZA tablets (150 mg each) 2 times a day and 99 women were given placebo 2 times a day. A placebo is a pill that doesn’t contain any active medication.

RESULTS

70% less risk with LYNPARZA vs placebo in SOLO-2

The primary results of the study showed that in women who were given LYNPARZA, their disease progression was delayed by a median of more than 1.5 years (19.1 months). In women who were given placebo, their disease progression was delayed by a median of 5.5 months.

70% less risk

LYNPARZA reduced the risk of cancer growing, spreading, or getting worse by 70% compared with placebo.

The primary results of the study showed that in women who were given LYNPARZA, their disease progression was delayed by a median of more than 1.5 years (19.1 months). In women who were given placebo, their disease progression was delayed by a median of 5.5 months.

  • 43%
  • After 2 years of taking LYNPARZA, 43% of women did not have their disease progress, compared with 15% of women who took placebo instead.

SAFETY

The most common adverse reactions included anemia, nausea, vomiting, diarrhea, mouth sores, sinus issues, tiredness or weakness, loss of appetite, joint or muscle pain, changes in how food tastes, and headache. Other adverse reactions included a low count of white blood cells, rash, cough, indigestion, low levels of magnesium, dizziness, low number of blood platelets, increase in creatinine, and swelling. Because of an adverse reaction, 45% of women interrupted treatment with LYNPARZA and 18% interrupted treatment with placebo; 27% of women had their LYNPARZA doses reduced and 3% had their placebo doses reduced; and 11% of women stopped treatment with LYNPARZA and 2% stopped treatment with placebo. These are not the only side effects associated with LYNPARZA.

LYNPARZA Study 19 Design

STUDY DESIGN

LYNPARZA was studied in 265 women with platinum-sensitive recurrent ovarian cancer—regardless of whether or not they had a BRCA mutation. 136 women were given 8 LYNPARZA capsules (50 mg each) 2 times a day and 129 women were given placebo 2 times a day. A placebo is a pill that doesn’t contain any active medication.

Although capsules were used in Study 19, capsules are not indicated for maintenance treatment. As of September 1, 2018, capsules are no longer available in the United States.

RESULTS

65% less risk with LYNPARZA vs placebo in Study19

65% less risk

LYNPARZA reduced the risk of cancer growing, spreading, or getting worse by 65% compared with placebo.

The primary results of the study showed that in women who were given LYNPARZA, their disease progression was delayed by a median of 8.4 months. In women who were given placebo, their disease progression was delayed by a median of 4.8 months.

65% less risk

LYNPARZA reduced the risk of cancer growing, spreading, or getting worse by 65% compared with placebo.

  • 13%
  • of women in the study (18 patients) remained on LYNPARZA for at least 5 years. 1% of women (1 patient) remained on placebo for 5 years.

SAFETY

The most common adverse reactions included anemia, nausea, vomiting, diarrhea, constipation, indigestion, tiredness or weakness, respiratory tract infection, loss of appetite, and headache. Other adverse reactions included changes in the way food tastes, dizziness, shortness of breath, fever, mouth sores, swelling, increase in creatinine, a low count of white blood cells, and low number of blood platelets. Because of an adverse reaction, 35% of women interrupted treatment with LYNPARZA and 10% interrupted treatment with placebo; 26% of women had their LYNPARZA doses reduced and 4% had their placebo doses reduced; and 6% of women stopped treatment with LYNPARZA and 2% stopped treatment with placebo. These are not the only side effects associated with LYNPARZA.

LYNPARZA Study 42

STUDY DESIGN

LYNPARZA was studied in 137 women with an inherited BRCA mutation and advanced ovarian cancer that came back after 3 or more rounds of chemotherapy. Women were given 8 LYNPARZA capsules (50 mg each) 2 times a day.

RESULTS

LYNPARZA was shown to shrink tumors in 34% of women. Of those who responded to treatment, 2% had a complete response (which means their cancer went away completely, but this is not the same as a cure), and 32% had a partial response.

Response was defined as either tumor shrinkage by at least 30% (partial response) or no detectable tumor on a CT or MRI scan (complete response).

7.9 months
The median length of response to treatment with LYNPARZA was 7.9 months. The length of responses ranged from 5.6 to 9.6 months. Length of response was measured as the time before the cancer started to progress again. Not all women responded to treatment.

6.7 months
In women who were given LYNPARZA, their disease progression was delayed by a median of 6.7 months.

SAFETY

The most common adverse reactions included anemia, decreased appetite, nausea, vomiting, diarrhea, indigestion, tiredness or weakness, sinus or respiratory issues, and joint or muscle pain. Other adverse reactions included cough, constipation, changes in how food tastes, swelling of the arms or legs, back pain, dizziness, headache, urinary tract infection, difficulty breathing, and rash. Because of an adverse reaction, 40% of women interrupted treatment with LYNPARZA; 4% of women had their LYNPARZA doses reduced; and 7% of women stopped treatment with LYNPARZA. These are not the only side effects associated with LYNPARZA.

CT=computed tomography; MRI=magnetic resonance imaging.

Ask your Doctor

Ask your health care provider what LYNPARZA may do for you.

Important Safety Information

WHAT IS LYNPARZA?

LYNPARZA is a prescription medicine used to treat adults who have:

  • advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
  • ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
  • advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

It is not known if LYNPARZA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

LYNPARZA may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer or breast cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.

Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.

Your healthcare provider will do blood tests to check your blood cell counts:

  • before treatment with LYNPARZA
  • every month during treatment with LYNPARZA
  • weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve

Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.

Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions, including if you:

  • have lung or breathing problems
  • have kidney problems
  • are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage)
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant
  • are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.

How should I take LYNPARZA?

  • Take LYNPARZA tablets exactly as your healthcare provider tells you
  • Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
  • Your healthcare provider will decide how long you stay on treatment
  • Do not take more than 4 LYNPARZA tablets in 1 day. If you have any questions about LYNPARZA, talk to your healthcare provider or pharmacist
  • Take LYNPARZA by mouth 2 times a day
  • Each dose should be taken about 12 hours apart
  • Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets
  • Take LYNPARZA with or without food
  • If you miss a dose of LYNPARZA, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose
  • If you take too much LYNPARZA, call your healthcare provider or go to the nearest hospital emergency room right away

What should I avoid while taking LYNPARZA?

Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood.

LYNPARZA may cause serious side effects. The most common side effects of LYNPARZA are:

  • nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms
  • low number of red or white blood cells
  • stomach-area (abdominal) pain
  • dizziness
  • tiredness or weakness
  • sore throat or runny nose
  • diarrhea
  • joint, muscle, and back pain
  • headache
  • constipation
  • mouth sores
  • respiratory tract infections
  • changes in kidney function blood test
  • changes in the way food tastes
  • loss of appetite
  • low number of platelets
  • indigestion or heartburn

These are not all the possible side effects of LYNPARZA. Call your healthcare provider for medical advice about side effects.

You may report side effects related to AstraZeneca products by clicking here.

Please click here for complete Prescribing Information, including Patient Information (Medication Guide).