FDA grants tentative approval to generic olaparib tablets across previously approved indications

The FDA has granted tentative approval to generic olaparib tablets (100 mg and 150 mg) for use across previously approved indications for the reference listed drug, olaparib (Lynparza), NATCO Pharma announced in a July 20, 2026, news release.¹

The tentative approval indicates that the generic application has met the agency's standards for bioequivalence but cannot receive final approval because of existing patent or exclusivity protections or other legal considerations.² In this case, NATCO noted that Paragraph IV patent litigation is ongoing.

Olaparib is currently indicated in the US as a single agent for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) and in combination with abiraterone acetate (Zytiga) and prednisone for patients with BRCA-mutated mCRPC. The agent also has indications across ovarian, breast, and pancreatic cancer.³

Data on olaparib

The most recent label expansion for olaparib was granted in May 2023, when the FDA approved the agent in combination with abiraterone and prednisone/prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated mCRPC, as determined by an FDA-approved companion diagnostic test.⁴

The approval was supported by data from the phase 3 PROpel trial (NCT03732820), which demonstrated that adding olaparib to frontline abiraterone acetate and prednisone/prednisolone significantly improved radiographic progression-free survival (rPFS) compared with abiraterone and prednisone/prednisolone alone in patients with mCRPC.

Investigators enrolled 796 patients with mCRPC. Patients were randomly assigned 1:1 to receive olaparib at 300 mg twice daily plus abiraterone at 1000 mg daily (n = 399) or placebo and abiraterone at 1000 mg daily (n = 397) in the first-line setting.

In the overall ITT population, the median investigator-assessed rPFS was 24.8 months with olaparib/abiraterone vs 16.6 months with placebo/abiraterone, translating to a 34% reduction in the risk of radiographic disease progression or death (HR, 0.66; 95% CI, 0.54 to 0.81; P < .0001).

Among patients with BRCA-positive mCRPC (11% of ITT population) the addition of olaparib to abiraterone led to a 76% reduction in the risk of disease progression or death vs abiraterone alone (HR, 0.24; 95% CI, 0.12 to 0.45) and a 70% reduction in the risk of death (HR, 0.3; 95% CI, 0.15 to 0.59). The median rPFS was not reached in the olaparib with abiraterone arm compared to 8 months (95% CI, 6 to 15) for those receiving placebo with abiraterone.⁵

In contrast, among patients without BRCA mutations (89% of ITT population), the addition of olaparib only led to a 23% reduction in the risk of disease progression or death (HR, 0.77; 95% CI, 0.63 to 0.96) and no significant reduction in the risk of death (HR, 0.92; 95% CI, 74 to 1.14). According to the FDA, these findings suggested that the rPFS benefit in the overall ITT population was primarily attributed to patients in the BRCA-positive population.

REFERENCES