Last updated: February 19, 2026
Summary
NDC 62135-0192, identified as Olaparib manufactured by AstraZeneca, is a poly (ADP-ribose) polymerase (PARP) inhibitor approved for the treatment of specific types of ovarian, breast, pancreatic, and prostate cancers. The drug's market performance is driven by its efficacy in homologous recombination deficiency (HRD)-positive cancers and its expanding indications. Market projections indicate continued growth, influenced by factors including patent expiry, emergence of generic competition, and ongoing clinical research for new applications. Pricing strategies for Olaparib are complex, reflecting its specialty status, R&D investment, and payer negotiations.
What is NDC 62135-0192?
NDC 62135-0192 corresponds to Olaparib, marketed by AstraZeneca under the brand name Lynparza. It is an oral small molecule inhibitor of PARP enzymes (PARP-1, PARP-2, and PARP-3). PARP enzymes are critical for DNA repair, particularly single-strand break repair. In cancers with defects in homologous recombination repair (HRR), such as those with BRCA1/2 mutations, inhibiting PARP can lead to synthetic lethality, selectively killing cancer cells while sparing normal cells.
Approved Indications and Patient Populations
Olaparib's approved indications target specific cancer types with defined genetic markers:
- Ovarian Cancer:
- Maintenance treatment of adult patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy. Patients must have a BRCA mutation (germline or somatic). [1]
- Maintenance treatment of adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are in response (complete or partial) to two or more prior lines of platinum-based chemotherapy. Patients must have a BRCA mutation (germline or somatic). [1]
- Breast Cancer:
- Treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative, metastatic breast cancer who have previously received an anthracycline or a taxane. Patients who have received prior chemotherapy for metastatic disease must have been treated with at least two lines of chemotherapy. [1]
- Adjuvant treatment of adult patients with gBRCAm, HER2-negative, high-risk early breast cancer who have completed definitive local treatment and have received or are ineligible for neoadjuvant chemotherapy. [1]
- Pancreatic Cancer:
- Treatment of adult patients with a germline BRCA-mutated (gBRCAm), metastatic pancreatic cancer who have an objectively stable disease following at least 16 weeks of a first-line platinum-based chemotherapy regimen. [1]
- Prostate Cancer:
- Treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) metastatic castration-resistant prostate cancer (mCRPC) who have progressed following at least one prior androgen receptor-targeting agent and have no more than two prior novel hormonal regimens. [1]
- Treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic castration-resistant prostate cancer (mCRPC) who have progressed following one prior novel hormonal regimen and have no prior treatment with an
