Ovarian Cancer

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Current Approvals

Three PARP inhibitors are currently approved for ovarian cancer as of May 2019. The latest information on FDA drug approvals can be found here and on EMA here.

Click on each agent to find out more:

• Olaparib
• Rucaparib
• Niraparib

Olaparib

First-line Maintenance

Dec 2018 (Food and Drug Administration, FDA) and June 2019 (European Medicines Agency, EMA): As maintenance treatment of adult patients with BRCA-mutated (germline and/or somatic, as detected by an FDA-approved companion diagnostic test) advanced/high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy [1, 2].

Second-line Maintenance

Dec 2014 (EMA): As monotherapy as maintenance treatment of platinum-sensitive relapsed BRCA-mutated (germline or somatic) high-grade serous ovarian cancer patients who are in response (complete or partial) to platinum-based chemotherapy [3, 4].

Aug 2017 (FDA): As maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy (tablet formulation) [5, 6].

Monotherapy (≥3 prior therapies)

Dec 2014 (FDA): As monotherapy for the treatment of germline BRCA1/2 mutated (as detected by an FDA-approved test) advanced ovarian cancer patients that have been treated with three or more prior lines of chemotherapy (capsule formulation) [6, 7]. 

Rucaparib

Second-line Maintenance

Apr 2018 (FDA): As maintenance treatment of patients with recurrent epithelial, fallopian tube or primary peritoneal ovarian cancer who are in a complete or partial response to platinum-based chemotherapy [8, 9].

Jan 2019 (EMA): As maintenance treatment of patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

Monotherapy (≥2 prior therapies)

Dec 2016 (FDA): As monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube or primary peritoneal cancer who have been treated with two or more chemotherapies (patient selection using an FDA-approved companion diagnostic for rucaparib) [9, 10].

May 2018 (EMA): As monotherapy treatment for patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy [11, 12].

Niraparib

Second-line Maintenance

Mar 2017 (FDA): As monotherapy for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumours have a complete or partial response to platinum-based chemotherapy [13, 14].

Sept 2017 (EMA): As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy [12, 15]. 

References

1. Food and Drug Administration. FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based. 2018.
2. European Medicines Agency. Lynparza: EPAR - Product Information. 2019.
3. European Medicines Agency. Olaparib EPAR and history of approval. 2019.
4. European Medicines Agency. Olaparib Summary of Product Characteristics. 2019.
5. Food and Drug Administration. FDA approves olaparib tablets for maintenance treatment in ovarian cancer. 2017.
6. AstraZeneca. LYNPARZA® (olaparib) tablets for oral use. 2018.
7. Food and Drug Administration. Olaparib. 2014.
8. Food and Drug Administration. FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. 2018.
9. Clovis Oncology. RUBRACA® (rucaparib) tablets, for oral use. 2018.
10. Food and Drug Administration. Rucaparib. 2016.
11. European Medicines Agency. Rucaparib EPAR and history of approval. 2018
12. European Medicines Agency. Rucaparib Summary of Product Characteristics. 2018
13. Food and Drug Administration. Niraparib. 2017.
14. Tesaro. ZEJULA® (niraparib) capsules, for oral use [prescribing information]. 2018.
15. European Medicines Agency. Niraparib EPAR and history of approval. 2018.