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Next-line ibrutinib
Next-line ibrutinib is a BTK inhibitor Small molecule drug developed by Pharmacyclics LLC.. It is currently in Phase 3 development for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Mantle cell lymphoma (MCL). Also known as: PCI-32765.
Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling in B cells and other immune cells, leading to reduced proliferation and survival of malignant B cells.
Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling in B cells and other immune cells, leading to reduced proliferation and survival of malignant B cells. Used for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Mantle cell lymphoma (MCL).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Next-line ibrutinib |
|---|---|
| Also known as | PCI-32765 |
| Sponsor | Pharmacyclics LLC. |
| Drug class | BTK inhibitor |
| Target | BTK (Bruton's tyrosine kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Ibrutinib irreversibly binds to and inhibits BTK, a key enzyme in the B-cell receptor signaling pathway. This inhibition prevents B-cell activation, proliferation, and migration, making it effective against B-cell malignancies. The drug also has activity against other kinases including TEC family kinases, contributing to its broader immunomodulatory effects.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Mantle cell lymphoma (MCL)
- Marginal zone lymphoma (MZL)
- Waldenström macroglobulinemia (WM)
Common side effects
- Diarrhea
- Fatigue
- Nausea
- Bruising/bleeding
- Infection
- Atrial fibrillation
- Rash
Key clinical trials
- A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (PHASE3)
- Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas (PHASE2)
- A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
- Phase 2 Study to Assess Activity & Safety of Front-line Ibrutinib + Rituximab in Unfit Chronic Lymphocytic Leukemia (PHASE2)
- Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE3)
- Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (PHASE1)
- Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma (PHASE2)
- A Study of TAK-659 in Combination With Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Participants With Advanced Non-Hodgkin Lymphoma (PHASE1)
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:
- Next-line ibrutinib CI brief — competitive landscape report
- Next-line ibrutinib updates RSS · CI watch RSS
- Pharmacyclics LLC. portfolio CI
Frequently asked questions about Next-line ibrutinib
What is Next-line ibrutinib?
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Related
- Drug class: All BTK inhibitor drugs
- Target: All drugs targeting BTK (Bruton's tyrosine kinase)
- Manufacturer: Pharmacyclics LLC. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocytic leukemia (CLL)
- Indication: Drugs for Small lymphocytic lymphoma (SLL)
- Indication: Drugs for Mantle cell lymphoma (MCL)
- Also known as: PCI-32765
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing