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MEDI4736 (Durvalumab)
MEDI4736 (Durvalumab) is a PD-L1 inhibitor Small molecule drug developed by Royal Marsden NHS Foundation Trust. It is currently in Phase 3 development for Unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy, Metastatic or unresectable locally advanced urothelial carcinoma, Biliary tract cancer. Also known as: Durvalumab.
Durvalumab is a monoclonal antibody that blocks PD-L1, preventing tumor cells from suppressing the immune system and allowing T cells to attack cancer.
Durvalumab is a monoclonal antibody that blocks PD-L1, preventing tumor cells from suppressing the immune system and allowing T cells to attack cancer. Used for Unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy, Metastatic or unresectable locally advanced urothelial carcinoma, Biliary tract cancer.
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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 | MEDI4736 (Durvalumab) |
|---|---|
| Also known as | Durvalumab |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Durvalumab binds to programmed death ligand 1 (PD-L1) on tumor cells and immune cells, blocking the PD-L1/PD-1 interaction that normally suppresses anti-tumor immunity. By preventing this inhibitory signal, the drug restores T cell activation and proliferation, enabling the immune system to recognize and eliminate cancer cells. This mechanism is particularly effective in tumors with high PD-L1 expression.
Approved indications
- Unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy
- Metastatic or unresectable locally advanced urothelial carcinoma
- Biliary tract cancer
- Gastric or gastroesophageal junction adenocarcinoma
Common side effects
- Fatigue
- Pneumonitis
- Diarrhea
- Nausea
- Decreased appetite
- Immune-mediated hepatitis
- Immune-mediated colitis
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial (PHASE3)
- Durvalumab as Consolidation for Patients LS-SCLC (PHASE2)
- Durvalumab With Gemcitabine and Cisplatin for the Treatment of High-Risk Resectable Liver Cancer Before Surgery (PHASE2)
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer (PHASE2)
- MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma (PHASE2)
- Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy (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:
- MEDI4736 (Durvalumab) CI brief — competitive landscape report
- MEDI4736 (Durvalumab) updates RSS · CI watch RSS
- Royal Marsden NHS Foundation Trust portfolio CI
Frequently asked questions about MEDI4736 (Durvalumab)
What is MEDI4736 (Durvalumab)?
How does MEDI4736 (Durvalumab) work?
What is MEDI4736 (Durvalumab) used for?
Who makes MEDI4736 (Durvalumab)?
Is MEDI4736 (Durvalumab) also known as anything else?
What drug class is MEDI4736 (Durvalumab) in?
What development phase is MEDI4736 (Durvalumab) in?
What are the side effects of MEDI4736 (Durvalumab)?
What does MEDI4736 (Durvalumab) target?
Related
- Drug class: All PD-L1 inhibitor drugs
- Target: All drugs targeting PD-L1
- Manufacturer: Royal Marsden NHS Foundation Trust — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Unresectable stage III non-small cell lung cancer (NSCLC) after concurrent chemoradiotherapy
- Indication: Drugs for Metastatic or unresectable locally advanced urothelial carcinoma
- Indication: Drugs for Biliary tract cancer
- Also known as: Durvalumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing