<p>Lynparza is a cancer medicine used for:</p><ul><li>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:<ul><li>women whose cancer has come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has shrunk or cleared the cancer;</li><li>women newly diagnosed with advanced cancer with mutations (changes) in one or both genes known as <em>BRCA1</em> and <em>BRCA2</em> who have been treated with platinum-based chemotherapy and in whom this treatment has shrunk or cleared the cancer;</li><li>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 <em>BRCA1</em> and <em>BRCA2</em>) and in whom platinum-based chemotherapy and bevacizumab has shrunk or cleared the cancer;</li></ul></li><li>treatment of HER2-negative breast cancer (when the cancer cells do not have high levels of a protein called HER2) in patients with <em>BRCA1</em> or <em>BRCA2</em> mutations when the cancer:<ul><li>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;</li><li>has spread beyond the original site after treatment with certain breast cancer medicines that have stopped working or were not suitable;</li></ul></li><li>continuing treatment of pancreatic cancer in patients with mutations in <em>BRCA1 </em>or<em> BRCA2</em> 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;</li><li>treatment of metastatic prostate cancer in:<ul><li>men with mutations in <em>BRCA1</em> or <em>BRCA2 </em>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;</li><li>men in whom medical or surgical treatment to lower testosterone levels (castration) did not work and in whom chemotherapy is not an option;</li></ul></li><li>continuing treatment of endometrial cancer, a cancer of the lining of the womb, that is mismatch repair proficient (pMMR, meaning that the cancer cells contain certain proteins that correct mistakes when DNA in dividing cells is copied), when the cancer is advanced or has come back (recurrent). It is used in combination with durvalumab (another cancer medicine) after treatment with chemotherapy and durvalumab has been completed.</li></ul><p>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, abiraterone together with prednisone or prednisolone in prostate cancer and durvalumab in endometrial cancer.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p><strong>Ovarian cancer</strong></p><p>Lynparza is indicated as monotherapy for the:</p><ul><li>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.</li><li>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.</li></ul><p>Lynparza in combination with bevacizumab is indicated for the:</p><ul><li>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).</li></ul><p><strong>Breast cancer</strong></p><p>Lynparza is indicated as:</p><ul><li>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).</li><li>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.</li></ul><p><strong>Adenocarcinoma of the pancreas</strong></p><p>Lynparza is indicated as:</p><ul><li>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.</li></ul><p><strong>Prostate cancer</strong></p><p>Lynparza is indicated as:</p><ul><li>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.</li><li>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).</li></ul><p><strong>Endometrial cancer</strong></p><p>Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with <a>carboplatin and paclitaxel</a>.</p></div>
Therapeutic Area (MeSH)
ATC Code
L01XK01
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| olaparib | N/A | olaparib |
EMA Name
Lynparza
Medicine Name
Lynparza
Aliases
N/ANo risk management plan link.
