Lynparza FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 28, 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

Further information

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