Lynparza

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 the capsules must be taken without food while tablets can be taken with or without food.

Treatment should start no later than 8 weeks after the patient has completed their chemotherapy and continue for as long as the disease is not getting worse.

The medicine can only be obtained with a prescription. 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 enzymes called human poly (ADP ribose) polymerase (PARP), which help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division. Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.

Studies show that Lynparza increases the time patients can live without their disease getting worse after initial treatment with a platinum chemotherapy has reduced or cleared the tumours.

A study of 295 patients with recurring cancer of the ovary, fallopian tube or peritoneum showed that those patients who took Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients who took placebo (a dummy treatment).

In another study involving 265 patients, 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.

The most common side effects with Lynparza (which may affect more than 1 in 10 people) are fatigue (tiredness), nausea (feeling sick), vomiting, diarrhoea, dyspepsia (heartburn), headache, dysgeusia (taste disturbances), decreased appetite, dizziness, anaemia (low red blood cell counts) and cough. For the full list of side effects and restrictions with Lynparza, see the package leaflet.

Patients with ovarian, fallopian tube or peritoneal cancers generally have a poor outcome. Lynparza can increase the time these patients live without their disease getting worse, thereby delaying their next cycle of platinum chemotherapy.

The side effects seen 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.