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Arm A - Olaparib
Arm A - Olaparib is a PARP inhibitor Small molecule drug developed by GERCOR - Multidisciplinary Oncology Cooperative Group. It is currently in Phase 2 development for Maintenance treatment of platinum-sensitive relapsed ovarian cancer, Maintenance treatment of platinum-sensitive relapsed, BRCA mutated, advanced ovarian cancer. Also known as: AZD-2281.
Olaparib is a PARP inhibitor that blocks the enzyme PARP1, preventing cancer cells from repairing DNA damage.
Olaparib is a PARP inhibitor that blocks the enzyme PARP1, preventing cancer cells from repairing DNA damage. Used for Maintenance treatment of platinum-sensitive relapsed ovarian cancer, Maintenance treatment of platinum-sensitive relapsed, BRCA mutated, advanced ovarian cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Arm A - Olaparib |
|---|---|
| Also known as | AZD-2281 |
| Sponsor | GERCOR - Multidisciplinary Oncology Cooperative Group |
| Drug class | PARP inhibitor |
| Target | PARP1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
By inhibiting PARP1, olaparib causes DNA damage in cancer cells, leading to cell death. This mechanism is particularly effective in cancers with BRCA1 or BRCA2 mutations, which are defective in DNA repair.
Approved indications
- Maintenance treatment of platinum-sensitive relapsed ovarian cancer
- Maintenance treatment of platinum-sensitive relapsed, BRCA mutated, advanced ovarian cancer
Common side effects
- Nausea
- Vomiting
- Fatigue
- Anemia
- Thrombocytopenia
Key clinical trials
- A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer (PHASE2)
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
- Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations (PHASE2)
- APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation (PHASE2)
- Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial (PHASE2)
- Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Arm A - Olaparib CI brief — competitive landscape report
- Arm A - Olaparib updates RSS · CI watch RSS
- GERCOR - Multidisciplinary Oncology Cooperative Group portfolio CI
Frequently asked questions about Arm A - Olaparib
What is Arm A - Olaparib?
How does Arm A - Olaparib work?
What is Arm A - Olaparib used for?
Who makes Arm A - Olaparib?
Is Arm A - Olaparib also known as anything else?
What drug class is Arm A - Olaparib in?
What development phase is Arm A - Olaparib in?
What are the side effects of Arm A - Olaparib?
What does Arm A - Olaparib target?
Related
- Drug class: All PARP inhibitor drugs
- Target: All drugs targeting PARP1
- Manufacturer: GERCOR - Multidisciplinary Oncology Cooperative Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Maintenance treatment of platinum-sensitive relapsed ovarian cancer
- Indication: Drugs for Maintenance treatment of platinum-sensitive relapsed, BRCA mutated, advanced ovarian cancer
- Also known as: AZD-2281
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing