What is Lynparza - olaparib used for?
Lynparza is a cancer medicine indicated for the treatment of "maintenance" of adult patients with high grade serous epithelial ovarian cancer (a type of advanced ovarian carcinoma), including carcinoma of the fallopian tubes (a part of the reproductive system female connecting the ovaries to the uterus) and the carcinoma of the peritoneum (the lining of the abdomen). Lynparza is used in patients with mutations (defects) in one of the two genes known as BRCA1 and BRCA2 and which show recurrent recurrences (ie recurrence of carcinoma after a treatment). Lynparza is administered after therapy with platinum-based medicines, when the size of the carcinoma has decreased or the tumor mass has completely disappeared. It is given to patients in whom previous therapy with platinum-based medicines has produced a lasting response (lasting at least 6 months). Lynparza contains the active substance olaparib . Because the number of patients with ovarian cancer is low, the disease is considered 'rare' and Lynparza was designated an 'orphan medicine' (a medicine used in rare diseases) on 6 December 2007.
How is Lynparza used - olaparib?
Lynparza is available as capsules (50 mg) to be taken by mouth. The medicine can only be obtained with a prescription and treatment must be started and supervised by a doctor who specializes in treating cancer. Before starting therapy, patients should make sure they have a BRCA gene mutation. Evaluation of mutation status must be performed in an appropriate laboratory using genetic testing. Treatment with Lynparza should be started within 8 weeks of taking the last dose of platinum-based chemotherapy. The recommended dose of Lynparza is 400 mg (eight capsules) to be taken twice a day. Treatment can be stopped and doses can be reduced in case of side effects. Lynparza should be taken at least one hour after food intake and patients should refrain from eating preferably up to two hours later. For more information, see the package leaflet.
How does Lynparza work - olaparib?
The active ingredient in Lynparza, olaparib, blocks the action of human enzymes called poly (ADP-ribose) polymerase (PARP), which contribute to the repair of damaged DNA in cells (both healthy and cancerous) during cell division. In healthy cells there is an alternative mechanism for repairing DNA that requires the BRCA1 and BRCA2 proteins. This alternative mechanism does not work properly in tumor cells that exhibit mutations in the BRCA1 or BRCA2 gene. Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired and, as a result, cancer cells die.
What benefit has Lynparza - olaparib shown during the studies?
Lynparza has been shown to increase the time period during which patients do not show a worsening of the disease in one main study involving 265 patients with high-grade serous ovarian carcinomas, including fallopian tube carcinoma or peritoneal carcinoma. The patients had undergone two or more courses of platinum-based chemotherapy and had a lasting response (the tumor had not progressed for at least 6 months) before the last therapeutic cycle. This response to platinum-based medicines justified the use of the last platinum-based treatment. Lynparza was administered within 8 weeks of the last course of platinum-based chemotherapy when the tumor mass was in recession or had completely disappeared. About half of the patients participating in the study had BRCA mutations. In most cases these were inherited mutations. Patients with a BRCA mutation treated with Lynparza survived on average longer without showing signs of disease progression compared to patients with a BRCA mutation treated with placebo (a dummy treatment), or 11.2 months compared with 4.3 months .
What is the risk associated with Lynparza - olaparib?
The most common side effects of Lynparza (which may affect more than 1 in 10 people) are tiredness, nausea, vomiting, diarrhea, dyspepsia (heartburn), headache, dysgeusia (taste disturbance), decreased appetite, dizziness, anemia (decrease in the number of red blood cells in the blood), lymphopenia and neutropenia (decrease in the number of certain types of white blood cells), increase in the average corpuscular volume (increase in the average size of red blood cells) and increase in creatinine (the presence of high levels of creatinine in the blood indicate problems with renal function). For the full list of all side effects reported with Lynparza, see the package leaflet. Breastfeeding is contraindicated during treatment with Lynparza and at least one month after the last dose. For the full list of limitations, see the package leaflet.
Why has Lynparza - olaparib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lynparza's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP is of the opinion that the benefit of Lynparza in prolonging the survival of cancer patients with a BRCA mutation before disease progression is clinically relevant. In these patients, who usually have a poor diagnosis, there was an overall delay of 6.9 months in the progression of the disease, which could allow the subsequent platinum-based chemotherapy cycle to be delayed. Regarding safety, the side effects were mostly mild or moderate and, in general, proved to be manageable. The CHMP also noted that further studies are needed to further confirm the benefit of Lynparza, its effects on overall survival and its long-term safety.
What measures are being taken to ensure the safe and effective use of Lynparza - olaparib?
A risk management plan has been developed to ensure that Lynparza is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lynparza, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Lynparza will perform studies to further confirm the benefit of the medicine, including the long-term benefit in patients with ovarian cancer.
More information on Lynparza - olaparib
On 16 December 2014, the European Commission issued a marketing authorization for Lynparza, valid throughout the European Union. For more information about treatment with Lynparza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The summary of the opinion of the Committee for Orphan Medicinal Products related to Lynparza is available on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / Rare disease designation. Last update of this summary: 12-2014.
