Lynparza FDA Approval History
Last updated by Judith Stewart, BPharm on June 7, 2023.
FDA Approved: Yes (First approved December 19, 2014)
Brand name: Lynparza
Generic name: olaparib
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer, Pancreatic Cancer, Prostate Cancer
Lynparza (olaparib) is a poly ADP ribose polymerase (PARP) inhibitor for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.
- Lynparza tablets are indicated:
Ovarian Cancer
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- for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
- in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:
- a deleterious or suspected deleterious BRCA mutation, and/or
- genomic instability.
- for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
Breast Cancer
-
- for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
- for the treatment of adult patients with deleterious or suspected deleterious gBRCAm, HER2 negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
Pancreatic Cancer
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- for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
Prostate Cancer
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- for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.
- in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
- Lynparza contains olaparib, which is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular functions, such as DNA transcription and DNA repair. Lynparza works as a targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
- Lynparza tablets are administered orally twice daily with or without food.
- Warnings and precautions associated with Lynparza include myelodysplastic syndrome/acute myeloid leukemia, pneumonitis, venous thromboembolism, and embryo-fetal toxicity.
- Common adverse reactions as a single agent include nausea, fatigue (including asthenia), anemia, vomiting, diarrhea, decreased appetite, headache, dysgeusia, cough, neutropenia, dyspnea, dizziness, dyspepsia, leukopenia, and thrombocytopenia.
Common adverse reactions in combination with bevacizumab include nausea, fatigue (including asthenia), anemia, lymphopenia, vomiting, diarrhea, neutropenia, leukopenia, urinary tract infection, and headache.
Common adverse reactions in combination with abiraterone and prednisone or prednisolone were anemia, fatigue, nausea, diarrhea, decreased appetite, lymphopenia, dizziness, and abdominal pain.
Lynparza capsules were permanently discontinued from the U.S. market on August 31, 2018.
Development timeline for Lynparza
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
