For women with ovarian cancer that has returned

After chemotherapy, LYNPARZA may be able to help

After chemotherapy, LYNPARZA may be able to help

Don’t take on ovarian cancer alone

LYNPARZA is a type of targeted therapy called a PARP inhibitor.

Cancer happens when cells grow out of control. Because of this growth, cancer cells have a higher risk of accumulating DNA damage. To help fix this damage and survive, the cancer cells rely on several different methods of repair, including one that involves the PARP enzyme.

By helping to stop PARP from working, LYNPARZA can limit a cancer cell’s ability to repair DNA damage. And that can lead to cancer cell death. LYNPARZA may also impact other cells and tissues in the body.

LYNPARZA may be used at different stages in a woman’s treatment journey:

When cancer comes back and is responding to chemotherapy

  • LYNPARZA can be used to help keep recurrent ovarian cancer from coming back or getting worse after it has responded to chemotherapy. This is called maintenance treatment.
  • LYNPARZA is for women with recurrent ovarian cancer that has come back and is responding to platinum-based chemotherapy.
  • When cancer is responding to treatment, it means that the tumors are shrinking or disappearing. It’s important to help maintain this progress after chemotherapy has ended.

 

When cancer comes back after 3 or more chemotherapy treatments

  • LYNPARZA can also be used to help shrink or slow the growth of advanced ovarian cancer. This is different from maintenance treatment, because the cancer is not currently in response to chemotherapy.
  • LYNPARZA is for women with an inherited BRCA mutation and advanced ovarian cancer who have received 3 or more chemotherapy treatments. Your health care provider will perform a test to make sure that LYNPARZA is right for you.
  • BRCA mutations are changes that can occur in your genes. These changes can be inherited from a parent, and can make cancerous cells more likely to be killed by a PARP inhibitor.

PARP=poly (ADP-ribose) polymerase.

Two studies tested LYNPARZA as a maintenance treatment

The purpose of each study was to see how safe and effective LYNPARZA is as a treatment for women with platinum-sensitive recurrent ovarian cancer. Platinum-sensitive means that the cancer has responded to a platinum-based treatment. The main difference between the 2 studies:

  • SOLO-2 studied LYNPARZA in women with an inherited BRCA mutation
  • Study 19 studied LYNPARZA in women regardless of whether or not they had a BRCA mutation

There are a few ways for researchers to see if LYNPARZA is working. In both studies, health care providers measured how long LYNPARZA delayed disease progression, which means they measured how long women lived without their cancer getting worse. Health care providers also measured CA-125 levels, whether or not tumors responded to LYNPARZA, and how long tumors responded to LYNPARZA.

STUDY DESIGN

LYNPARZA was studied in 295 women with an inherited BRCA mutation and recurrent ovarian cancer who were sensitive 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

In SOLO-2 study, women with BRCA-mutated ovarian cancer given LYNPARZA®(olaparib) lived longer without cancer growth compared to placebo.

70% less risk

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

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.

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 this study used capsules, LYNPARZA capsules are not FDA approved for use as a maintenance treatment.

RESULTS

Women with platinum-sensitive relapsed ovarian cancer given LYNPARZA®(olaparib) have a reduced risk of cancer spreading.

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, tiredness or weakness, respiratory tract infection, loss of appetite, and headache. Other adverse reactions included indigestion, mouth sores, changes in the way food tastes, dizziness, increase in creatinine, a low count of white blood cells, low number of blood platelets, difficulty breathing, fever, and swelling. 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.

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 for:

  • The maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
  • The treatment of adults who have a certain type of abnormal inherited BRCA gene advanced ovarian cancer and have received treatment with 3 or more prior types of chemotherapy medicines. Your health care 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 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 health care 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 health care 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 health care provider may stop treatment with LYNPARZA until your blood cell counts improve

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

Before you take LYNPARZA, tell your health care provider about all your medical conditions, including if you:

  • Have lung or breathing problems
  • Have liver problems
  • Have kidney problems
  • Are 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 health care 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 receiving the last dose of LYNPARZA
    • Talk to your health care provider about birth control methods that may be right for you
    • Tell your health care 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 health care provider about the best way to feed your baby during this time

Tell your health care 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 health care provider tells you
  • Your health care provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
  • LYNPARZA comes as tablets and capsules. LYNPARZA tablets and capsules are not the same. If your health care provider prescribes LYNPARZA tablets for you, do not take LYNPARZA capsules. Do not take more than 4 LYNPARZA tablets in 1 day. If you have any questions about LYNPARZA, talk to your health care 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 health care 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 health care provider if you get nausea or vomiting. Your health care provider may prescribe medicines to treat these symptoms
  • Tiredness or weakness
  • Diarrhea
  • Headache
  • Changes in kidney function blood test
  • Low number of platelets
  • Changes in the way food tastes
  • Loss of appetite
  • Low number of red or white blood cells
  • Mouth sores
  • Respiratory infections
  • Indigestion or heartburn
  • Sore throat or runny nose
  • Upper respiratory infection
  • Cough
  • Pain in the joints, muscles, and back
  • Rash
  • Pain or discomfort in the stomach area

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.1-800-FDA-1088

Please see complete Prescribing Information for LYNPARZA tablets and complete Prescribing Information for LYNPARZA capsules, including Patient Information (Medication Guides).