FDA Approves Bioequivalent Olaparib Across Previously Approved Cancer Indications

The FDA has granted tentative approval to 100-mg and 150-mg bioequivalent formulations of olaparib for use across approved labelling indications for the reference listed drug, olaparib (Lynparza), according to an announcement from NATCO Pharma.¹

Olaparib is currently approved by the FDA²:

• 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 (Avastin) 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 deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
• for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, 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 germline BRCA-mutated, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor–positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy
• for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
• 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 (Xtandi) or abiraterone (Zytiga)
• in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated mCRPC

All indications call for treatment selection to be based on an FDA-approved companion diagnostic for olaparib.

The FDA’s most recent approval of olaparib arrived in May 2023, when the regulatory agency green-lit the PARP inhibitor in combination with prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated mCRPC.³

This approval was back by data from the phase 3 PROpel trial (NCT03732820), which showed that within the BRCA-mutated subgroup of patients, the median radiographic progression-free survival (rPFS) was not yet reached in the experimental arm vs 8 months (95% CI, 6-15) for those treated with placebo plus abiraterone and prednisone/prednisolone (HR, 0.24; 95% CI, 0.12-0.45).

The median overall survival (OS) was not yet reached in the olaparib arm vs 23 months (95% CI, 18-34) in the control arm (HR, 0.30; 95% CI, 0.15-0.59).

References

1. NATCO receives tentative approval for olaparib tablets from the United States Food and Drug Administration (U.S. FDA). News release. NATCO Pharma. July 20, 2026. Accessed July 21, 2026. https://www.natcopharma.co.in/insights/news-and-announcements
2. Lynparza. Prescribing information. Updated July 2025. Accessed July 21, 2026. https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/00997c3f-5912-486f-a7db-930b4639cd51/00997c3f-5912-486f-a7db-930b4639cd51_viewable_rendition__v.pdf
3. FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer. FDA. May 31, 2023. Accessed July 21, 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-olaparib-abiraterone-and-prednisone-or-prednisolone-brca-mutated-metastatic-castration