FDA Grants Additional Approval to LYNPARZA® (olaparib) Tablets

We would like to inform you that the US Food and Drug Administration (FDA) has granted approval for LYNPARZA® (olaparib) tablets (300mg twice daily) as a maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients, who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status.

In addition, the twice-daily tablet dose reduces the pill count from 16 capsules to four tablets per day for use in adult patients with deleterious or suspected deleterious germline BRCA- (gBRCA) mutated advanced ovarian cancer treated with LYNPARZA who have had three or more prior lines of chemotherapy. Patients for this indication are selected for therapy based on an FDA-approved companion diagnostic. 

While LYNPARZA tablets are approved for both indications, LYNPARZA capsules (400mg twice daily) will still be available through a limited specialty pharmacy network for patients being treated in the late-line setting. LYNPARZA capsules are not indicated for maintenance treatment.

LYNPARZA was first approved under the FDA’s Accelerated Approval program in December 2014, as a capsule formulation, making it the first FDA-approved poly ADP-ribose polymerase (PARP) inhibitor. Since then, more than 3,000 advanced ovarian cancer patients have been treated with LYNPARZA capsules. 

The FDA approval of LYNPARZA tablets is based on data from two randomized ovarian cancer trials in the platinum-sensitive maintenance setting: 

· SOLO-2, which showed that LYNPARZA reduced the risk of disease progression or death by 70% and improved median progression-free survival (PFS) by 19.1 vs 5.5 months, compared with placebo in gBRCA-mutated patients (HR 0.30 [95% CI, 0.22-0.41], P<0.0001).

· Study 19, which showed that LYNPARZA reduced the risk of disease progression or death by 65% with a median PFS of 8.4 vs 4.8 months, compared with placebo in patients of any BRCA status (HR 0.35 [95% CI, 0.25-0.49], P<0.0001).

· Most common adverse reactions (≥20%) in clinical trials were anemia, nausea, fatigue (including asthenia), vomiting, nasopharyngitis/upper respiratory tract infection/influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis. Most common laboratory abnormalities (≥25%) were decrease in hemoglobin, increase in mean corpuscular volume, decrease in lymphocytes, decrease in leukocytes, decrease in absolute neutrophil count, increase in serum creatinine and decrease in platelets.

o In the SOLO-2 trial, discontinuation of LYNPARZA resulting from adverse events was seen in 11% of patients. Dose interruptions of LYNPARZA due to an adverse reaction of any grade was 45%. Dose reductions of LYNPARZA due to an adverse reaction was 27%.

o In the Study 19 trial, discontinuation of LYNPARZA resulting from adverse events was seen in 6% of patients. Dose interruptions of LYNPARZA due to an adverse

reaction of any grade was 35%. Dose reductions of LYNPARZA due to an adverse reaction was 26%.

Please see Important Safety Information below.

Here is a link to the full press release announcing the FDA approval, issued by AstraZeneca, to ensure you are prepared to respond to potential inquiries that your organization may receive.

To learn more, please visit https://www.lynparzahcp.com/home.html

As always, please do not hesitate to reach out with any questions.

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)

o If you are able to become pregnant, your health care provider may do a pregnancy test before you start treatment with LYNPARZA

o 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

o Talk to your health care provider about birth control methods that may be right for you

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