Lynparza
Authorised
This medicine is authorised for use in the European Union
olaparib
MedicineHumanAuthorised
Overview
Lynparza is a cancer medicine used for:
- continuing treatment after initial treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb), and the peritoneum (membrane lining the abdomen) in:
- women whose cancer has come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has shrunk or cleared the cancer;
- women newly diagnosed with advanced cancer with mutations (changes) in one or both genes known as BRCA1 and BRCA2 who have been treated with platinum-based chemotherapy and in whom this treatment has shrunk or cleared the cancer;
- women with advanced cancer that is HRD-positive (homologous recombination deficiency; where one of the mechanisms to repair damaged DNA does not work, which can be due to a defect in certain genes such as BRCA1and BRCA2) and in whom platinum-based chemotherapy and bevacizumab has shrunk or cleared the cancer;
- treatment of HER2-negative breast cancer (when the cancer cells do not have high levels of a protein called HER2) in patients with BRCA1 or BRCA2 mutations when the cancer:
- has not spread to other parts of the body following chemotherapy given before or after surgery (early breast cancer), but there is a high risk of the cancer coming back;
- has spread beyond the original site after treatment with certain breast cancer medicines that have stopped working or were not suitable;
- continuing treatment of pancreatic cancer in patients with mutations in BRCA1 or BRCA2 genes that is metastatic (has spread to other parts of the body) and has not worsened after at least 4 months of platinum-based chemotherapy;
- treatment of metastatic prostate cancer in:
- men with mutations in BRCA1 or BRCA2 genes in whom medical or surgical treatment to lower testosterone levels (castration) did not work and whose cancer has worsened after treatment with other prostate cancer medicines, including a new hormonal agent;
- men in whom medical or surgical treatment to lower testosterone levels (castration) did not work and in whom chemotherapy is not an option.
Lynparza contains the active substance olaparib. It is either used alone or in combination with other cancer medicines like bevacizumab in ovarian cancer, hormone therapy in breast cancer and abiraterone together with prednisone or prednisolone in prostate cancer.
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 which the patient takes twice a day.
The dose of Lynparza depends on what disease it is being used for. Treatment is continued for as long as the patient benefits from it and does not have unmanageable side effects. 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 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 worsened 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 worsened 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 on its own was effective in patients with BRCA1 or BRCA2 mutations (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.
In a study of 796 men with metastatic and castration-resistant prostate cancer, Lynparza in combination with abiraterone and prednisone or prednisolone (hormone therapy) increased the time patients lived without their disease getting worse: those receiving Lynparza and hormone therapy lived on average 24.8 months without their disease getting worse, compared with 16.6 months in those treated with placebo (a dummy treatment) and hormone therapy.
The most common side effects with Lynparza (which may affect more than 1 in 10 people) are nausea (feeling sick), tiredness, anaemia (low levels of red blood cells), vomiting, diarrhoea, decreased appetite, headache, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), dysgeusia (taste disturbances), cough, leucopenia (low levels of white blood cells), dizziness, dyspnoea (difficulty breathing) and dyspepsia (heartburn).
The most common severe side effects (which may affect more than 2 in 100 people) are anaemia, neutropenia, tiredness, leucopenia and thrombocytopenia (low levels of blood platelets).
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 cancer and for patients with HER2-negative breast cancer, pancreatic cancer with BRCA mutations or castration-resistant prostate cancer with or without 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 cancer, 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 and prostate 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.
Product information
Latest procedure affecting product information: IB/0067
05/01/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Lynparza
- Active substance
- Olaparib
- International non-proprietary name (INN) or common name
- olaparib
- Therapeutic area (MeSH)
- Ovarian Neoplasms
- Breast Neoplasms
- Pancreatic Neoplasms
- Prostatic Neoplasms, Castration-Resistant
- Anatomical therapeutic chemical (ATC) code
- L01XK01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Ovarian cancer
Lynparza is indicated as monotherapy for the:
- maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
- maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.
Lynparza in combination with bevacizumab is indicated for the:
- maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1).
Breast cancer
Lynparza is indicated as:
- monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).
- monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
Adenocarcinoma of the pancreas
Lynparza is indicated as:
- monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
Prostate cancer
Lynparza is indicated as:
- monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
- in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1).
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