Loading
If this is the first time anyone has visited this substance, we may be fetching live data from TGA Product Information, PBS, and state framework sources — that can take up to a minute. Cached substances load in a second or two.
Olaparib, sold under the brand name Lynparza, is a medication for the maintenance treatment of BRCA-mutated advanced ovarian cancer in adults. It is a PARP inhibitor, inhibiting poly ADP ribose polymerase (PARP), an enzyme involved in DNA repair. It acts against cancers in people with hereditary BRCA1 or BRCA2 mutations, which include some ovarian, breast, and prostate cancers.
Read the full article on WikipediaHigh grade epithelial ovarian, fallopian tube or primary peritoneal cancer Clinical criteria: Treatment Phase: Continuation of subsequent-line maintenance therapy (BRCA1/2 gene mutation) The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation), AND The treatment must be the sole PBS-subsidised therapy for this condition, AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Treatment criteria: Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer Clinical criteria: Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation) The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test, AND Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition, AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Treatment criteria: Patient must be undergoing treatment with this drug class for the first time; OR Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal. A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.
Castration resistant metastatic carcinoma of the prostate Clinical criteria: Treatment Phase: Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must not have developed disease progression while receiving treatment with this drug for this condition, AND The treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug. Treatment criteria: Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
Early breast cancer Clinical criteria: Treatment Phase: Initial treatment The condition must be human epidermal growth factor receptor 2 (HER2) negative, AND Patient must have received neoadjuvant or adjuvant chemotherapy, AND The treatment must be adjuvant to surgical resection, AND The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant, AND Patient must have received neoadjuvant chemotherapy, and residual invasive cancer is confirmed in the breast and/or resected lymph nodes (pathological complete response was not achieved); OR Patient must have received adjuvant chemotherapy for triple negative breast cancer, and has either: (a) node positive disease is present, (b) a primary tumour greater than 20 mm; OR Patient must have received adjuvant chemotherapy for hormone receptor positive breast cancer, and has at least 4 positive lymph nodes, AND The treatment must not be a PBS-subsidised benefit beyond the following, whichever comes first: (i) a total of 52 weeks of treatment (including any non-PBS-subsidised supply), (ii) disease recurrence. Mark any remaining repeat prescriptions with the word 'cancelled' where (i)/(ii) has occurred, AND The treatment must be commenced within 12 weeks of completing other therapy noting that other therapy can be any of the following therapy: (i) surgery, (ii) radiotherapy, (iii) chemotherapy, AND The treatment must not in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab, (iii) ribociclib. Retain all pathology imaging and investigative test results in the patient's medical records. Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).
Metastatic breast cancer Clinical criteria: Treatment Phase: Initial treatment The condition must be human epidermal growth factor receptor 2 (HER2) negative, AND The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant, AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less, AND Patient must have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting, AND Patient must not have received PBS-subsidised treatment with this drug in any earlier line of treatment for breast cancer, AND The condition must be triple negative breast cancer; OR The condition must be hormone-receptor positive breast cancer and the patient has either: (i) progressive disease after receiving endocrine therapy, (ii) been considered inappropriate for endocrine therapy, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication. Treatment criteria: Must be treated by a medical practitioner. Retain all pathology imaging and investigative test results in the patient's medical records. Do not submit copies of these as part of the authority application. Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).
“Olaparib acts as an inhibitor of the enzyme poly ADP ribose polymerase (PARP), and is termed a PARP inhibitor. BRCA1/2 mutations may be genetically predisposed to development of some forms of cancer, and may be resistant to other forms of cancer treatment. However, these cancers sometimes have a unique vulnerability, as the cancer cells have increased reliance on PARP to repair their DNA and enable them to continue dividing. This means that drugs which selectively inhibit PARP may be of benefit if the cancers are susceptible to this treatment.”
Working under the parallel aged-care framework? Aged-care equivalent →