Lynparza

Lynparza can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.

Lynparza is available as tablets (100 and 150 mg) and capsules (50 mg) which the patient takes twice a day. A lower dose is required for the tablets than for the capsules. While tablets can be taken with food or between meals, the patient should take the capsules at least 1 hour after food and not eat for up to 2 hours afterwards.

The dose and the choice between capsules and tablets of Lynparza depends on what disease it is being used for. Treatment is continued for as long as the patient benefits from it. In advanced ovarian cancer, the doctor may stop treatment after 2 years if X-rays show no signs of the cancer. In early breast cancer, patients should be treated for up to 1 year. Treatment may be interrupted or stopped, or the dose reduced if certain side effects develop.

For more information about using Lynparza, see the package leaflet or contact your doctor or pharmacist.

The active substance in Lynparza, olaparib, blocks the action of an enzyme called human poly ADP ribose polymerase (PARP), which helps to repair damaged DNA in cells (both in normal and cancer cells) during cell division. Cancer cells with mutations such as the BRCA1 or BRCA2 mutations rely more heavily on PARP to repair their DNA and continue dividing. Therefore, when PARP is blocked, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.

Ovarian cancer

Studies show that Lynparza given on its own increases the time women with cancer of the ovary, fallopian tube or peritoneum live without their disease getting worse after treatment with platinum-based chemotherapy has shrunk or cleared the cancer:

• A study involving 295 patients with relapsed cancer found that those receiving Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients receiving placebo (a dummy treatment).

• In another study involving 265 patients with relapsed cancer, those who took Lynparza lived on average for 8.4 months without their disease getting worse compared with 4.8 months for patients on placebo.

• In a third study involving 391 patients with advanced cancer who had BRCA1 or BRCA2 mutations, the disease did not get worse in around 74% of patients who took Lynparza for 2 years compared with 35% of patients on placebo.

When given with bevacizumab, Lynparza increases the time patients with HRD-positive cancer live without their disease getting worse after treatment with platinum-based chemotherapy and bevacizumab has shrunk or cleared the cancer. In a main study of 806 patients with advanced high-grade ovarian, fallopian tube or peritoneal cancer, patients whose cancer was HRD-positive and who took Lynparza for 22 months lived on average 37.2 months without their disease getting worse compared with 17.7 months for those receiving placebo.

Breast cancer

Lynparza was effective in a study involving 302 patients with HER2-negative breast cancer with BRCA1 or BRCA2 mutations whose cancer had spread. Patients treated with Lynparza lived on average 7.0 months without their disease getting worse compared with 4.2 months for patients treated with the doctor’s choice of another cancer medicine.

Another study involved 1,836 patients with BRCA1 or BRCA2 mutations and HER2-negative breast cancer which had not spread to other parts of the body after chemotherapy treatment given before or after surgery. The study showed that Lynparza was effective at preventing the disease from coming back when given alone or together with hormone therapy. Lynparza was given to 921 patients, a placebo was given to 916 patients, and all patients were allowed to have hormone therapy. After 3 years, the disease had got worse or spread in 12% of patients treated with Lynparza compared with 20% of patients taking placebo.

Pancreatic cancer

In a study of 154 patients with BRCA1 or BRCA2 mutations who had metastatic pancreatic cancer that had not got worse during at least 4 months of treatment with platinum-based chemotherapy, Lynparza increased the time patients lived without their disease getting worse: those receiving Lynparza lived on average 7.4 months without their disease getting worse compared with 3.8 months for patients receiving placebo.

Prostate cancer

In a study of 387 men with metastatic castration-resistant prostate cancer whose cancer had worsened during treatment with another cancer medicine, Lynparza was effective in patients with mutations in BRCA1 or BRCA2 genes (160 patients overall): Patients with these mutations and treated with Lynparza lived on average 9.8 months without their disease getting worse, compared with 3.0 months in those treated with the doctor's choice of another cancer medicine.

The most common side effects with Lynparza (which may affect more than 1 in 10 people) are nausea (feeling sick), tiredness, anaemia (low red blood cell counts), vomiting, diarrhoea, decreased appetite, headache, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), cough, dysgeusia (taste disturbances), leucopenia (low white blood cell counts), dizziness, dyspnoea (difficulty breathing) and dyspepsia (heartburn).

The most common severe side effects (which may affect more than 2 in 100 people) are low blood cell counts, low levels of neutrophils, tiredness, low white blood cell counts and thrombocytopenia (low blood platelet counts).

Women must not breastfeed during treatment with Lynparza and for a month after stopping treatment.

For the full list of side effects and restrictions with Lynparza, see the package leaflet.

Generally, the outcome is poor for patients with ovarian, fallopian tube, or peritoneal cancers and for patients with HER2-negative breast cancer, pancreatic cancer with BRCA mutations or prostate cancer with BRCA mutations whose cancer has spread. Lynparza can increase the time these patients live without their disease getting worse. In ovarian, fallopian tube or peritoneal cancers, Lynparza can also delay the need for the next cycle of platinum chemotherapy.

The side effects with Lynparza are mostly mild or moderate and are generally manageable. The European Medicines Agency therefore decided that Lynparza’s benefits are greater than its risks and it can be authorised for use in the EU.

The company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit, of the medicine in patients with ovarian cancer.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lynparza have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lynparza are continuously monitored. Side effects reported with Lynparza are carefully evaluated and any necessary action taken to protect patients.

Lynparza received a marketing authorisation valid throughout the EU on 16 December 2014.