Lynparza FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on May 21, 2020.

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 first-in-class oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

Lynparza tablets are indicated:

• Ovarian Cancer
  • 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
  • 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.
    Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
  • 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.
  • for the treatment of adult patients with deleterious or suspected deleterious germline BRCA mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
• Breast Cancer
  • 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
• Pancreatic Cancer
  • 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
• Prostate Cancer
  • 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. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

Lynparza capsules were permanently discontinued from the U.S. market on August 31, 2018.

Development Timeline for Lynparza

Date	Article
May 20, 2020	Lynparza Approved in the US for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
May  8, 2020	Lynparza (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
Dec 30, 2019	Lynparza (olaparib) Approved in the US as a First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer
Dec 19, 2018	Lynparza (olaparib) Approved by US FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer
Jan 12, 2018	FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer
Aug 17, 2017	FDA Approves Tablet Formulation of Lynparza (olaparib) for Maintenance Treatment of Ovarian Cancer
Dec 19, 2014	FDA Approves Lynparza (olaparib) to Treat Advanced Ovarian Cancer
Jun 25, 2014	FDA Advisory Committee Votes on Accelerated Approval for Investigational Medicine Olaparib

Further information

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