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. The doses in milligrams are different for the tablets and capsules. Furthermore, 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 disease does not get worse. In advanced ovarian cancer, the doctor may stop treatment after 2 years if X-rays show no signs of the cancer. 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 the BRCA1/2 mutations rely more heavily on PARP to repair their DNA and continue dividing. Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.

Ovarian cancer

Studies show that Lynparza increases the time patients live without their disease getting worse after treatment with platinum-based chemotherapy has reduced or cleared the cancer:

• A study of 295 patients with relapsed cancer of the ovary, fallopian tube or peritoneum 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 BRCA1/2 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.

Breast cancer

Lynparza was effective in a study involving 302 patients with HER2-negative breast cancer with BRCA1/2 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.

Pancreatic cancer

In a study of 154 patients with BRCA1/2 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.

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

The most common severe side effects are the changes in blood cell counts, tiredness, weakness and vomiting.

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 or pancreatic 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 next cycle of platinum chemotherapy.

The side effects with Lynparza were mostly mild or moderate and were 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.